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 22-41 are pending and examined on the merits.
Claims 1-21 are cancelled.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/11/2026, with respect to the rejection(s) of claims 22-41 under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tout (U.S. Pre Grant Pub. No. 2013/0123723 A1).
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.
Claims 22-27 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. In claim 22, lines 3 and 6, the terms “substantially concentric” are indefinite as it isn’t clear if the substantial concentric configuration causes an overlap of the lumens. As per para. [0007 and 0027] of the instant Specification, it appears that Applicant intends that “substantially concentric” to mean that the porous configuration is what is substantially concentric. Appropriate revision is needed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 22-36, and 37-40 are rejected under pre-AIA 35 U.S.C. 102(a)(2) as being anticipated by Tout (U.S. Pre Grant Pub. No. 2013/0123723 A1).
Regarding claim 22, Tout teaches: An apparatus for managing fluid from a tissue site (see at least Abstract and Fig. 1), comprising:
a lumen (see space left after removal of inner-core member 155 in Fig. 7; para. [0062] teaches that the inner-core member 155 is removable).
a first porous wall (see first longitudinal concentric member 120 in Figs. 1 and 7; para. [0030] teaches that the first longitudinal concentric member 120 is formed from an open-cell foam) positioned substantially concentric about the lumen (see at least para. [0032] and Fig. 7), wherein the first porous wall has an open porous structure defining a plurality of interconnected pores in fluid communication with one another (see para. [0030] teaching that the first longitudinal concentric member 120 is formed from an open-cell foam, which will naturally have a plurality of interconnected pores in fluid communication with one another; see also para. [0038]); and
a second porous wall (see second longitudinal concentric member 124 in Figs. 1 and 7; para. [0033] teaches that the second longitudinal concentric member 124 is micro-porous) positioned substantially concentric about the first porous wall (see at least para. [0033] and Fig. 7), wherein the second porous wall has an open porous structure defining a plurality of interconnected pores in fluid communication with one another (see para. [0033] teaching that the second longitudinal concentric member 124 is micro-porous, which will naturally have a plurality of interconnected pores in fluid communication with one another; see also para. [0038]).
Regarding claim 23, Tout teaches the invention as discussed above in claim 22. Additionally, Tout teaches wherein the first porous wall (120) and the second porous wall (124) are each comprised of bonded particles that define the interconnected pores of the first porous wall and the interconnected pores of the second porous wall (para. [0038] teaches that a porous foam may include a plurality of interconnected cells or pores that act as flow channels).
Regarding claim 24, Tout teaches the invention as discussed above in claim 22. Additionally, Tout teaches further comprising a barrier layer positioned substantially concentric about the first porous wall (as broadly recited, and as shown in Fig. 1 and as taught in para. [0036], sealing member 136 is a barrier layer that is positioned substantially concentric about the proximal end 132 of tunnel-wound dressing 102, which comprises the first porous wall 120).
Regarding claims 25-26, Tout teaches the invention as discussed above in claim 24. Additionally, Tout teaches wherein the barrier layer is comprised of a non-porous material (para. [0036] teaches that the sealing member 136 is impermeable) and wherein the non-porous material is liquid impermeable and hydrophobic (para. [0036] teaches that the sealing member 136 is impermeable).
Regarding claim 27, Tout teaches the invention as discussed above in claim 22. Additionally, Tout teaches wherein the apparatus has an insertion end (see distal end 130 in Fig. 1) and an external end (see proximal end 132 in Fig. 1), the external end further comprising an external barrier layer positioned substantially concentric about the second porous wall (as broadly recited, and as shown in Fig. 1 and as taught in para. [0036], sealing member 136 is a barrier layer that is positioned substantially concentric about the proximal end 132 of tunnel-wound dressing 102, which comprises the second porous wall 124), wherein the external barrier layer is comprised of a non-porous, liquid impermeable material (para. [0036] teaches that the sealing member 136 is impermeable).
Regarding claim 28, Tout teaches the invention as discussed above in claim 22. Additionally, Tout teaches wherein the lumen comprises two or more lumens (see for example liquid conduits 158 in Fig. 8 and para. [0054]).
Regarding claim 29, Tout teaches: An apparatus for managing fluid from a tissue site (see at least Abstract and Fig. 1), comprising:
a lumen (see space left after removal of inner-core member 155 in Fig. 7; para. [0062] teaches that the inner-core member 155 is removable);
a first circumferential wall (see first longitudinal concentric member 120 in Figs. 1 and 7) surrounding the lumen (see at least para. [0032] and Fig. 7), the first circumferential wall having a first open porous structure (para. [0030] teaches that the first longitudinal concentric member 120 is formed from an open-cell foam); and
a second circumferential wall (see second longitudinal concentric member 124 in Figs. 1 and 7) surrounding the first circumferential wall (see at least para. [0033] and Fig. 7), the first circumferential wall between the lumen and the second circumferential wall (see at least Fig. 7), the second circumferential wall having a second open porous structure (para. [0033] teaches that the second longitudinal concentric member 124 is micro-porous).
Regarding claim 30, Tout teaches the invention as discussed above in claim 29. Additionally, Tout teaches further comprising a barrier layer between the first circumferential wall and the second circumferential wall (as broadly recited, and as shown in Fig. 1 and as taught in para. [0036], sealing member 136 is a barrier layer that is positioned at the proximal end 132 of tunnel-wound dressing 102, which is between the first porous wall 120 and the second porous wall 124).
Regarding claim 31, Tout teaches the invention as discussed above in claim 30. Additionally, Tout teaches wherein the barrier layer is comprised of a non-porous material (para. [0036] teaches that the sealing member 136 is impermeable).
Regarding claim 32, Tout teaches the invention as discussed above in claim 29. Additionally, Tout teaches wherein the apparatus has an insertion end (see distal end 130 in Fig. 1) and an external end (see proximal end 132 in Fig. 1), the external end further comprising an external barrier layer around the second porous wall (as broadly recited, and as shown in Fig. 1 and as taught in para. [0036], sealing member 136 is a barrier layer that is positioned substantially concentric about the proximal end 132 of tunnel-wound dressing 102, which comprises the second porous wall 124), wherein the external barrier layer is comprised of a non-porous, liquid impermeable material (para. [0036] teaches that the sealing member 136 is impermeable).
Regarding claim 33, Tout teaches the invention as discussed above in claim 29. Additionally, Tout teaches wherein the second circumferential wall includes a plurality of longitudinal depressions and a plurality of longitudinal protrusions disposed about an external circumference of the second circumferential wall (see plurality of facets 146 in Fig. 5 and para. [0035]).
Regarding claim 34, Tout teaches A system for treating a tissue site (see at least Abstract), comprising:
a manifold (see proximal end 132 in Fig. 1 and para. [0036]) configured to be positioned proximate the tissue site (see at least Fig. 1);
a cover layer (see sealing member 136 in Fig. 1 and para. [0036]) configured to cover the manifold and the tissue site (see Fig. 1 and para. [0036]) to provide a sealed space between the cover layer and the tissue site (see Fig. 1 and para. [0036]);
a porous conduit (see tunnel-wound dressing 102 at least in Fig. 1 and para. [0029]; see also para. [0030]) configured to be disposed in the sealed space in fluid communication with the manifold (see at least Fig. 1 and para. [0029]), comprising:
a lumen (see space left after removal of inner-core member 155 in Fig. 7; para. [0062] teaches that the inner-core member 155 is removable),
a first circumferential wall (see first longitudinal concentric member 120 in Figs. 1 and 7) extending around the lumen (see at least para. [0032] and Fig. 7), the first circumferential wall having a porous structure (para. [0030] teaches that the first longitudinal concentric member 120 is formed from an open-cell foam), the first circumferential wall in fluid communication with the lumen (para. [0030] teaches that the first longitudinal concentric member 120 transmits fluids);
a first barrier layer extending around the first circumferential wall (as broadly recited, and as shown in Fig. 1 and as taught in para. [0036], sealing member 136 is a barrier layer that is positioned substantially concentric about the proximal end 132 of tunnel-wound dressing 102, which comprises the first porous wall 120), the first barrier layer comprising a non-porous material (para. [0036] teaches that the sealing member 136 is impermeable); and
a therapy device (see reduced-pressure source 144 in Fig. 1) adapted to be in fluid communication with the porous conduit (see at least para. [0008]), the therapy device comprising a reduced-pressure source configured to be in fluid communication with the lumen (see at least Fig. 1 and para. [0008]).
Regarding claim 35, Tout teaches the invention as discussed above in claim 34. Additionally, Tout teaches wherein the manifold is adapted to distribute reduced pressure to the tissue site (para. [0036] teaches that reduced pressure is maintained at proximal end 132), and wherein the manifold is comprised of a porous hydrophobic foam (para. [0036] teaches that the tunnel-wound dressing 102 has the proximal end 132; para. [0038] teaches that the manifold is porous and hydrophobic).
Regarding claim 36, Tout teaches the invention as discussed above in claim 34. Additionally, Tout teaches wherein the porous conduit has an insertion end positioned within the sealed space (see distal end 130 in Fig. 1) and an external end positioned exterior to the sealed space (see for example reduced-pressure interface 140 in Fig. 1), the external end coupled in fluid communication to the therapy device (see at least Fig. 1).
Regarding claim 41, Tout teaches the invention as discussed above in claim 34. Additionally, Tout teaches wherein the porous conduit has an external surface comprising a plurality of longitudinal depressions and a plurality of longitudinal protrusions disposed about an external circumference of the porous conduit and extending lengthwise along a length of the porous conduit (see plurality of facets 146 in Fig. 5 and para. [0035]).
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 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 31 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tout (U.S. Pre Grant Pub. No. 2013/0123723 A1).
Regarding claim 31, Tout teaches the invention as discussed above in claim 29. However, Tout fails to explicitly teach a barrier layer between the first circumferential wall and the second circumferential wall, as required by the claim.
However, as broadly recited, the claim does not define what the barrier layer is or what it’s function is. Therefore, any layer between the first circumferential wall and the second circumferential wall can be considered to be a barrier layer. 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 have modified the device of Tout to duplicate second longitudinal concentric member 124 such that a duplicated second longitudinal concentric member 124 is disposed between the second longitudinal concentric member 124 and the first longitudinal concentric member 120 at least since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960); see also MPEP 2144.04). One of ordinary skill in the art would be reasonably motivated to duplicate the second longitudinal concentric member 124 at least in order to have multiple layers that inhibit in-growth of tissue, as taught by Tout (see para. [0033]).
Allowable Subject Matter
Claim 31 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: As described above, Tout teaches all the limitations of claims 29 and 30. However, Tout fails to teach or reasonably suggest, alone or in combination, that the barrier layer is comprised of a non-porous material, as required by the claim. Rather, Tout teaches that the second longitudinal concentric member 124 has a plurality of apertures (see para. [0030]). Therefore, even duplicate second longitudinal concentric member 124 (from claim 30) will have a plurality of apertures. Additionally, one of ordinary skill in the art would not have been motivated to make duplicate second longitudinal concentric member 124 comprise a non-porous material because such a modification would render Tout inoperative for its intended purpose, which is to apply reduced pressure to the second longitudinal concentric member 124 and the first longitudinal concentric member 120 (see Figs. 3B and 6B and para. [0049]). A non-porous layer between that second longitudinal concentric member 124 and the first longitudinal concentric member 120 would prevent negative pressure from being applied to the second longitudinal concentric member 124. In addition, one of ordinary skill in the art would not have been motivated to modify the device of Tout to have the claimed structural features without relying on impermissible hindsight (see MPEP 2141).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 22-41 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-22 of prior U.S. Patent No. 11,918,730. This is a statutory double patenting rejection. The claims of U.S. Patent No. 11,918,730 contain each and every limitation of claims 22-41 of the instant application as well as additional features. The claims of the US Patent are narrower than the claims of the instant application, and effectively anticipate the instant claims. Thus, the invention of the patent claims 1-22 are in effect a “species” of the “generic” invention of the instant claims 22-41. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781
