DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 2-21 are pending and examined on the merits. Claims 2, 10 & 21 are independent.
Information Disclosure Statement
The references cited by applicants in the information disclosure statements filed on 11/5/2024 have been made of record. Examiner has considered the voluminous references to the best of her ability.
While the statements filed do not comply with the guidelines set forth in MPEP 2004 regarding both the number of references cited and the elimination of clearly irrelevant art and marginally cumulative information, compliance with these guidelines is not mandatory. Furthermore, 37 CFR 1.97 and 1.98 does not require that the information be material; rather, they allow for submission of information regardless of its pertinence to the claimed invention. Also, there is no requirement to explain the materiality of the submitted references. However, the cloaking of a clearly relevant reference by inclusion in a long list of citations may not comply with Applicant’s duty of disclosure. See Penn Yan Boats, Inc. v. Sea Lark boats Inc., 359 F. Supp. 948, aff’d 479 F. 2d. 1338.
Applicant is advised that the MPEP states the following with respect to large information disclosure statements:
Although a concise explanation of the relevance of information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted. Concise explanations (especially those that point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more is highly relevant to patentability. MPEP § 609.04(a)(III).
This statement is in accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), states that forcing the Examiner to find “a needle in a haystack” is “probative of bad faith.” Id. at 1888. This case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references. Id. 1888.
The MPEP provides more support for this position. In a subsection entitled “Aids to Compliance With Duty of Disclosure,” item thirteen states:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant information and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to Applicant’s attention and/or are known to be of the most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp 948 (S.D. Fla. 1972) aff’d 479 F.2d 1338 (5th Cir 1974). See also MPEP § 2004.
Therefore, it is recommended that if any information that has been cited by Applicants in the previous disclosure statement is known to be material for patentability as defined by 37 CFR 1.56, Applicant should present a concise statement as to the relevance of that/those particular documents therein cited.
Claim Rejections - 35 USC § 112
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.
Claim 6 is 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.
Specifically, Claim 6 recites further comprising a conduit configured to transport exudate from the wound site to the collection canister. This conduit appears to be the same as the exudate conduit of Claim 4, from which Claim 6 depends. It is not clear if Applicant intends to simply recite that the exudate conduit of Claim 4 transports exudate to the collection canister (a function not previously recited in Claim 4), or if Applicant intends to recite a completely separate conduit that is different from the “exudate conduit” of Claim 4. Examiner assumes that the conduit in Claim 6 is the same as that of Claim 4, and Claim 6 merely explicitly recites that said exudate conduit transports exudate from the wound site to the collection canister.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 2-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lockwood et al. (US 2005/0004534) in view of Vogel (US 2007/0032762).
Re Claim 2, Lockwood discloses an apparatus (see Figs. 29-30) to provide negative pressure to a wound site, comprising:
an exudate channel (vacuum tube 441, Fig. 29) configured to be in fluid communication with a source of negative pressure (vacuum source 16);
a vent channel (vent line 462) configured to provide filtered air (through air filter 470, Fig. 29 & [0157]) to the wound site;
a layer (sealing layer 450, [0147], Fig. 30).
wherein, when negative pressure from the source of negative pressure is applied to the exudate channel to provide negative pressure to the wound site, fluid flow between the vent channel and the exudate channel is directed to pass from the vent channel toward the wound site and away from the wound site and into the exudate channel (see Fig. 29 where the entire vent channel is completely separated from the exudate channel, thus air/fluid flow needs to exit the vent channel and flow toward the wound site before entering the exudate channel, where it would be suctioned away from the wound site).
Lockwood does not disclose that the layer comprises a first aperture and a second aperture, wherein the exudate channel is in fluid communication with the first aperture and the vent channel is in fluid communication with the second aperture and therefore also does not disclose that the fluid flow passes toward the wound site through the first aperture and into the exudate channel through the second aperture. Lockwood instead discloses that the exudate channel and the vent channel are formed as separate tubes and the tubes extend under a peripheral edge of the sealing layer to reach the wound space sealed by the layer (see Fig. 30).
Vogel discloses a negative pressure wound treatment system (Fig. 1) comprising a wound sealing layer (cover 132) having first and second apertures (implied in Fig. 8 because inlet port 134 and suction port 135 are shown to be on opposite ends of the cover 132), wherein the first aperture is in fluid communication with an exudate channel (suction port 135 and tube 122) and the second channel is in fluid communication with a channel (tube 125 and port 134) that allows fluid into the wound space. It would have been obvious to one skilled in the art at the time of filing to modify Lockwood with Vogel’s teaching of putting apertures in the sealing layer and attaching the fluid outflow and fluid inflow tubes/ports to the apertures, respectively, because this may prevent the tubes (for exudate removal and venting) from coming into direct contact with wound tissue since the tubes no longer have to extend under the sealing layer periphery to reach the wound space.
Re Claim 3, Lockwood and Vogel combine to disclose Claim 2, and Lockwood further discloses comprising the source of negative pressure (16).
Re Claim 4, Lockwood and Vogel combine to disclose Claim 3, and Lockwood further discloses comprising an exudate conduit configured to be in fluid communication with the exudate channel and the source of negative pressure (see Fig. 29).
Re Claim 5, Lockwood and Vogel combine to disclose Claim 4, and Lockwood further discloses comprising a collection canister ([0067], waste canister 26 is taught in Application 10/159,583 incorporated by reference into Lockwood) configured to be in fluid communication with the source of negative pressure.
Re Claim 6, Lockwood and Vogel combine to disclose Claim 5, and Lockwood further discloses that the exudate conduit is configured for transporting exudate removed from the wound site to the collection canister when the system is in an operable state (Fig. 29).
Re Claim 7, Lockwood and Vogel combine to disclose Claim 2, and Lockwood also discloses a vent conduit configured to be in fluid communication with the vent channel (Fig. 29).
Re Claims 8-9, Lockwood and Vogel combine to disclose Claim 2, and Lockwood also discloses that the exudate channel is larger in cross-sectional size than the vent channel (evident from other embodiments showing the exudate channel being much greater than vent channels, see e.g., Fig. 21 where vacuum lumen 222 is greater than vent lumen 226), and wherein the exudate channel is at least twice as large in cross-sectional size as the vent channel (see [0113]).
Claims 10-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lockwood in view of Heaton (US 2007/0219512).
Re Claim 10, Lockwood discloses an apparatus for providing negative pressure to a wound site, comprising:
a wound dressing comprising a cover layer (sealing layer 450) configured to be positioned over a wound site;
an exudate channel (vacuum tube 441, Fig. 29) configured to be in fluid communication with a source of negative pressure (vacuum source 16) so that, in an operable state of the apparatus, fluid can be drawn through the exudate channel from at least the wound site by the source of negative pressure;
a vent channel (vent line 462) configured to provide filtered air (through air filter 470, Fig. 29 & [0157]) to be drawn through the exudate channel (since filtered air is delivered to the wound space under sealing layer 450, the filtered air would be drawn through the exudate channel when the suction source is activated);
wherein, when negative pressure from the source of negative pressure is applied to the exudate channel to provide negative pressure to the wound site, fluid flow between the vent channel and the exudate channel is directed to pass from the vent channel toward the wound site and away from the wound site through the exudate channel (see Fig. 29 where the entire vent channel is completely separated from the exudate channel, thus air/fluid flow needs to exit the vent channel and flow toward the wound site before entering the exudate channel, where it would be suctioned away from the wound site).
Lockwood does not disclose:
a port configured to be coupled with an outer surface of the cover layer, the port comprising:
a port body comprising a raised portion;
a flange surrounding the raised portion;
an adhesive on an underside surface of the port to adhere the port to the outer surface of the cover layer;
the exudate channel extending through at least part of the raised portion so that an end of the exudate channel terminates in alignment with an opening formed in the cover layer; and
the vent channel extending through at least part of the port body so that an end of the vent channel also terminates in alignment with the opening formed in the cover layer.
Heaton discloses a wound port (reduced pressure adapter 22, see e.g., Figs. 2 & 4) having a raised portion and a flange portion (clearly shown in Fig. 4), the wound port also having an exudate channel (center of recessed region 54) extending through the raised portion of the port body and two ancillary channels (via ancillary ports 56 & 58, Fig. 2) extending through the port body, wherein the exudate channel and the ancillary channels terminate in alignment with an opening in the cover layer (wound drape covers the wound and there must be an opening in the wound drape to allow wound exudate to pass from the wound into the port/adapter). Note that both exudate channel and ancillary channels in Heaton share one large opening 53 on the port’s bottom surface, therefore only one opening in the cover layer is needed for the wound to fluidly communicate with the channels. Heaton also discloses an adhesive on an underside of the port to adhere the port to the outer surface of the cover layer ([0045]). It would have been obvious to one skilled in the art at the time of filing to modify Lockwood by incorporating the port disclosed by Heaton and using the ancillary channels for venting such that there is a simpler way to organize the exudate/vent tubes used in the system. This also prevents putting the tubes under the sealing layer, which may cause accidental damage to the wound.
Re Claim 11, Lockwood and Heaton combine to disclose Claim 10, and Lockwood further discloses comprising the source of negative pressure (16).
Re Claim 12, Lockwood and Heaton combine to disclose Claim 11, and after the modification, Lockwood also discloses an exudate conduit (Fig. 29) that would necessarily be configured to be coupled with the port so that the exudate conduit is in fluid communication with the exudate channel and the source of negative pressure.
Re Claim 13, Lockwood and Heaton combine to disclose Claim 11, and Lockwood further discloses comprising a collection canister ([0067], waste canister 26 is taught in Application 10/159,583 incorporated by reference into Lockwood) configured to be in fluid communication with the source of negative pressure.
Re Claim 14, Lockwood and Vogel combine to disclose Claim 13, and Lockwood further discloses a conduit in fluid communication with the exudate channel and the collection canister (Fig. 29), the conduit configured for transporting exudate removed from the wound site to the collection canister when the system is in an operable state.
Re Claims 15-16, Lockwood and Heaton combine to disclose Claim 10, and Lockwood also discloses that the exudate channel is larger in cross-sectional size than the vent channel (evident from other embodiments showing the exudate channel being much greater than vent channels, see e.g., Fig. 21 where vacuum lumen 222 is greater than vent lumen 226), and wherein the exudate channel is at least twice as large in cross-sectional size as the vent channel (see [0113]).
Re Claims 17-18, Lockwood and Heaton combine to disclose Claim 10, and as shown in Heaton, the end of the vent channel (ancillary ports 56 & 58) is positioned adjacent to the end of the exudate channel (center of recessed region 54), and wherein the end of the vent channel is separated from the end of the exudate channel with a wall portion of either or both of the vent channel or the exudate channel (clearly shown in Fig. 2 where exudate channel is more recessed than ancillary ports 56 & 58).
Re Claim 19, Lockwood and Heaton combine to disclose Claim 10, and Heaton further implies at least one opening formed in the cover layer (as explained in Claim 10 supra), wherein, in an operable state, the end of the exudate channel and the end of the vent channel are positioned in alignment with the at least one opening.
Re Claim 20, Lockwood and Heaton combine to disclose Claim 10, Heaton also discloses wherein the exudate channel extends into the port body from one or more sides of the port body and turns downwardly inside the port body toward the underside surface of the port and wherein the vent channel (via ancillary ports 56 & 58) extends into the port body from the one or more sides of the port body and turns downwardly inside the port body toward the underside surface of the port (evident from Heaton Figs. 2 & 4-7).
Re Claim 21, Lockwood discloses an apparatus for providing negative pressure to a wound site, comprising:
a wound dressing comprising a cover layer (sealing layer 450) configured to be positioned over a wound site;
an exudate channel (vacuum tube 441, Fig. 29) configured to be in fluid communication with a source of negative pressure (vacuum source 16) so that, in an operable state of the apparatus, fluid can be drawn through the exudate channel from at least the wound site by the source of negative pressure;
a vent channel (vent line 462) configured to provide filtered air (through air filter 470, Fig. 29 & [0157]) to be drawn through the exudate channel (since filtered air is delivered to the wound space under sealing layer 450, the filtered air would be drawn through the exudate channel when the suction source is activated);
wherein:
when negative pressure from the source of negative pressure is applied to the exudate channel to provide negative pressure to the wound site, fluid flow between the vent channel and the exudate channel is directed to pass from the vent channel toward the wound site and away from the wound site through the exudate channel (see Fig. 29 where the entire vent channel is completely separated from the exudate channel, thus air/fluid flow needs to exit the vent channel and flow toward the wound site before entering the exudate channel, where it would be suctioned away from the wound site).
Lockwood does not disclose:
a port configured to be coupled with an outer surface of the cover layer, the port comprising:
a port body comprising a raised portion;
a flange surrounding the raised portion;
an adhesive on an underside surface of the port to adhere the port to the outer surface of the cover layer;
the exudate channel extending through at least part of the raised portion; and
the vent channel extending through at least part of the port body so that an end of the vent channel also terminates in alignment with the opening formed in the cover layer;
wherein: the exudate channel and the vent channel extend through at least part of the raised portion of the port body so that an end of the exudate channel terminates adjacent to an end of the vent channel.
Heaton discloses a wound port (reduced pressure adapter 22, see e.g., Figs. 2 & 4) having a raised portion and a flange portion (clearly shown in Fig. 4), the wound port also having an exudate channel (center of recessed region 54) extending through the raised portion of the port body and two ancillary channels (via ancillary ports 56 & 58, Fig. 2) extending through the port body, wherein the exudate channel and the ancillary channels terminate adjacent each other and in alignment with an opening in the cover layer (wound drape covers the wound and there must be an opening in the wound drape to allow wound exudate to pass from the wound into the port/adapter). Note that both exudate channel and ancillary channels in Heaton share one large opening (53) on the port’s bottom surface, therefore only one opening in the cover layer is needed for the wound to fluidly communicate with the channels. Heaton also discloses an adhesive on an underside of the port to adhere the port to the outer surface of the cover layer ([0045]). It would have been obvious to one skilled in the art at the time of filing to modify Lockwood by incorporating the port disclosed by Heaton and using the ancillary channels for venting such that there is a simpler way to organize the exudate/vent tubes used in the system. This also prevents putting the tubes under the sealing layer, which may cause accidental damage to the wound.
Conclusion
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
31 March 2026