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.
Claim 1 and therefore all depending claims (2-28) are interpreted under 112(f) due the phrase “comprising means for establishing fluid communication with a wound”. Applicant’s specification paragraph [0022] supports the structure being a connector such as a Luer Lock ® and equivalents thereof.
Claim 12 and therefor any depending claims (13) are interpreted under 112(f) due the phrase “comprising means for detecting the negative pressure that is applied to the wound”. Applicant’s specification paragraph [0015] supports a programable computer processor as an example or additionally a pressor sensor in paragraph [0027].
Claim Rejections - 35 USC § 112
Claim 10 contains the trademark/trade name Luer Lock. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe treaded connection and, accordingly, the identification/description is indefinite.
Regarding claim 26, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-7, 9-19 and 27 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Askem US 2018/0133378 A1.
With regards to claim 1, Askem discloses a device for negative pressure wound therapy (NPWT) (abstract), comprising: a source of negative pressure (or pump 400, fig 14, [0150]) and a single gas reservoir in fluid communication with the source of negative pressure (300, [0150], see element 300 is a single unit, fig 14) and comprising means for establishing fluid communication with a wound (or connector 302, [0146], fig 14).
With regards to claim 2, Askem discloses wherein the source of negative pressure is a vacuum pump, for example, a diaphragm vacuum pump ([0150] and [0230] which mentions diaphragm).
With regards to claim 3, Askem discloses wherein the source of reduced pressure has a maximum dimension of 100mm or less ([0135] discloses various dimensions and [0138] discloses the device is pocket size).
With regards to claim 4, Askem discloses wherein the source of reduced pressure is housed within a manifold ([0148]).
With regards to claim 5, Askem discloses wherein the single gas reservoir is in fluid communication with the source of reduced pressure via a vacuum port (or valve) located on the source of reduced pressure ([0156]).
With regards to claim 6, Askem discloses wherein a check valve is located between the source of reduced pressure and the single gas reservoir ([0156] which discloses a checked valve).
With regards to claim 7, Askem discloses wherein the check valve is a one-way valve that permits the flow of gas out of the single gas reservoir but that does not allow a flow of gas into the single gas reservoir ([0156]).
With regards to claim 9, Askem discloses, wherein the means comprised by the single gas reservoir, for establishing fluid communication with a wound, is a medical connector (302, [0146]).
With regards to claim 10, Askem discloses wherein the medical connector is a Luer lock ([0148] which notes the connector can have threads).
With regards to claim 11, Askem discloses, further comprising means for detecting the negative pressure that is applied to the wound (where in the means for detecting negative pressure can be done using a computer processor under 112f as seen above, [0257-0258] which discloses a processor for detecting negative pressure).
With regards to claim 12, Askem discloses wherein the means for detecting the negative pressure that is applied to the wound is operably coupled to the source of reduced pressure ([0257-0258] which discloses a processor for detecting negative pressure).
With regards to claim 13, Askem discloses, wherein the device comprises a programmable computer processor and the means for detecting the negative pressure that is applied to the wound is operably coupled to the source of reduced pressure via the programmable computer processor ([0257-0258] which discloses a processor for detecting negative pressure and [0227]).
With regards to claim 14, Askem discloses wherein the device is battery operated ([0136]).
With regards to claim 15, Askem discloses, wherein the device is for single-patient use ([0136]).
With regards to claim 16, Askem discloses wherein the device is disposable ([0136]).
With regards to claim 17, Askem discloses comprising a housing that accommodates the components of the device as defined in claim 1 ([0135]).
With regards to claim 18, Askem discloses, wherein the housing comprises a battery compartment ([0219]).
With regards to claim 19, Askem discloses a system for negative pressure wound therapy (NPWT), comprising a device for NPWT as claimed described in claim 1 and at least one wound dressing for NPWT (fig 56A and [0146]).
With regards to claim 27, Askem discloses method of negative pressure wound therapy (NPWT), comprising: applying a wound dressing for NPWT to a wound; establishing fluid communication between the wound dressing and the single gas reservoir of the device as claimed in claim 1; and activating the device ([0032]).
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.
Claim(s) 20-23 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Askem US 2018/0133378 A1 and in further view of Gowans US 2022/0387225 A1.
With regards to claim 20 and 28, Askem discloses wherein the wound dressing for NPWT is an island wound dressing (950, fig 57A).
Askem fails to disclose the details of the dressing: comprising a backing layer and a wound contacting layer, and an absorbent pad disposed between the backing layer and the wound contacting layer, the backing layer comprising an aperture which brings the absorbent pad into fluid communication with the exterior of the wound dressing.
With regards to claim 21, Askem fails to disclose wherein the aperture is located directly above or on top of the absorbent pad.
With regards to claim 22, Askem fails to disclose wherein the wound contacting layer is a layer of perforated silicone gel.
With regards to claim 23, Askem fails to disclose a a-moisture-permeable layer of pressure-sensitive adhesive, disposed between the backing layer and the absorbent pad, or between the absorbent pad and the wound contacting layer.
Regarding claims 20-23:
Gowans discloses a wound dressing for use with a negative pressure therapy device that is portable (fig 1b) thereby being in the same field of endeavor as the instant claims. Gowans teaches the dressing has a wound contacting layer (222, fig 2b, [0038]), and an absorbent pad (221, fig 2b, [0038]) disposed between the backing layer and the wound contacting layer ([0038]), the backing layer (220, fig 2b, [0038]) comprising an aperture (227, fib 2b, [0050])which brings the absorbent pad into fluid communication with the exterior of the wound dressing ([0050]). Gowans teaches the aperture is located directly above or on top of the absorbent pad (227, fig 2b, [0050]).
Gowans teaches the wound contacting layer is a layer of perforated silicone gel ([0041]). Gowans teaches a-moisture-permeable layer of pressure-sensitive adhesive, disposed between the backing layer and the absorbent pad, or between the absorbent pad and the wound contacting layer ([0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have used the dressing of Gowans with the device of Askem as Askem only provides a generic dressing that is able the used with negative wound therapy unit and Gowans appears to teach the same portable unit while focusing on the dressing details. Both patents are also commonly owned
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Askem US 2018/0133378 A1 and in further view of Garcia US 2010/0130949 A1.
With regards to claim 8, Askem discloses wherein the one- way valve ([0156]) but fails to disclose the type is selected from a diaphragm valve, a ball and spring valve and a swing/tilt valve.
Garcia teaches a drainage system thereby being drawn to the related flied of endevour and that diaphragm and ball valves are different types of one-way valves ([0141]).
Therefor it would have been obvious to one of ordinary skill before the effective filing date to have used a specific type of one- way valve as taught by Garcia instead of the generic one-way valve of Askem as there would be reasonable expectation of success given a one-way valve is still being used.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Askem US 2018/0133378 A1 and in further view of Locke US 2013/0144227 A1.
With regards to claim 24, Askem fails to disclose a plurality of wound dressings for NPWT.
Locke discloses a wound dressing for use with a negative pressure therapy device that is portable and connected to multiple dressings (fig 1) thereby being in the same field of endeavor as the instant claims.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added multiple dressing to the negative pressure device of Askem with a reasonable expectation of success as Locke shows it has been done and running more than one wound site off the same device would be easier for patient mobility and less waste in general.
Claim(s) 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Askem US 2018/0133378 A1 and in further view of Locke US 2013/0144227 A1 and Gowans US 2022/0387225 A1.
With regards to claim 25, Askem discloses wherein the wound dressing for NPWT is an island wound dressing (950, fig 57A).
Askem fails to disclose the details of the dressing: comprising a backing layer and a wound contacting layer, and an absorbent pad disposed between the backing layer and the wound contacting layer, the backing layer comprising an aperture which brings the absorbent pad into fluid communication with the exterior of the wound dressing.
With regards to claim 26, Askem discloses batteries ([0136]); suction tubing (or conduit, 954, fig 57A) ; a connector (302, fig 57A).
Askem fails to disclose sealing strips for attaching a dressing for NPWT to the skin of a patient.
Gowans discloses a wound dressing for use with a negative pressure therapy device that is portable (fig 1b) thereby being in the same field of endeavor as the instant claims. Gowans teaches the dressing has a wound contacting layer (222, fig 2b, [0038]), and an absorbent pad (221, fig 2b, [0038]) disposed between the backing layer and the wound contacting layer ([0038]), the backing layer (220, fig 2b, [0038]) comprising an aperture (227, fib 2b, [0050])which brings the absorbent pad into fluid communication with the exterior of the wound dressing ([0050]). Gowans teaches the aperture is located directly above or on top of the absorbent pad (227, fig 2b, [0050]). Gowans teaches sealing strips (or fixation strips, 1010, fig 5d) for attaching a dressing for NPWT to the skin of a patient ([0122]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have used the dressing of Gowans with the device of Askem as Askem only provides a generic dressing that is able the used with negative wound therapy unit and Gowans appears to teach the same portable unit while focusing on the dressing details. Both patents are also commonly owned
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA E BURNETTE whose telephone number is (571)272-9574. The examiner can normally be reached M-S: 0830-1900 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GABRIELLA E BURNETTE/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights