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.
Information Disclosure Statement
The two information disclosure statements (IDS’s) submitted on 01/26/2024 and 09/18/2024 were filed before the mailing date of the First Office Action on the Merits. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1 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 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 22-23, 28-29, and 33 are rejected under pre-AIA 35 U.S.C. 102(a)(2) as being anticipated by Johnson (U.S. Pre Grant Pub. No. 2007/0218101 A1).
Regarding claim 22, Johnson teaches: An apparatus for managing fluid from a tissue site (see at least para. [0007]), comprising:
a lumen (see channel 223 in Figs. 1-5 and para. [0070]).
a first porous wall (see flexible barrier 213 in Figs. 1-5 and para. [0069-0070]; additionally, para. [0071] teaches that the barrier can be permeable to liquids, air, or other gases) positioned substantially concentric about the lumen (as shown in Fig. 5, and as taught in para. [0069], the flexible barrier surrounds lumen 223), wherein the first porous wall has an open porous structure defining a plurality of interconnected pores in fluid communication with one another (see scaffold in para. [0072]); and
a second porous wall (see flexible backing 227 in Figs. 4A-B; additionally, para. [0071] teaches that the barrier can be permeable to liquids, air, or other gases) positioned substantially concentric about the first porous wall (as shown in Figs. 4A-B, and as taught in para. [0069], the flexible backing surrounds lumen 223), wherein the second porous wall has an open porous structure defining a plurality of interconnected pores in fluid communication with one another (see scaffold in para. [0072]).
Regarding claim 23, Johnson teaches the invention as discussed above in claim 22. Additionally, Johnson teaches wherein the first porous wall (213) and the second porous wall (227) 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. [0073] teaches that suitable scaffold material may include calcium phosphate; see also para. [0105 and 0127]).
Regarding claim 28, Johnson teaches the invention as discussed above in claim 22. Additionally, Johnson teaches wherein the lumen comprises two or more lumens (see Fig. 4B).
Regarding claim 29, Johnson teaches: An apparatus for managing fluid from a tissue site (see at least para. [0007]), comprising:
a lumen (see channel 223 in Figs. 1-5 and para. [0070]);
a first circumferential wall (see flexible barrier 213 in Figs. 1-5 and para. [0069-0070]) surrounding the lumen (as shown in Fig. 5, and as taught in para. [0069], the flexible barrier surrounds lumen 223), the first circumferential wall having a first open porous structure (see scaffold in para. [0072]); and
a second circumferential wall (see flexible backing 227 in Figs. 4A-B) surrounding the first circumferential wall (as shown in Figs. 4A-B, and as taught in para. [0069], the flexible backing surrounds lumen 223), the first circumferential wall between the lumen and the second circumferential wall (as broadly recited, the lumen is between the first and second circumferential wall; see Fig. 4A), the second circumferential wall having a second open porous structure (see scaffold in para. [0072]).
Regarding claim 33, Johnson teaches the invention as discussed above in claim 29. Additionally, Johnson 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 (para. [0115-0116] and Fig. 24 teach that the rolled cellular material 865 has a plurality of longitudinal depressions for radiopaque material 881 and protrusions for tube 869 disposed about an external circumference extending lengthwise).
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).
Claims 24-27 and 30-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Johnson (U.S. Pre Grant Pub. No. 2007/0218101 A1).
Regarding claim 24, Johnson teaches the invention as discussed above in claim 22. Additionally, in a separate embodiment, Johnson teaches further comprising a barrier layer (see impermeable membrane 871 in Figs. 23-25A) positioned substantially concentric about the first porous wall (as shown in Fig. 23 and as described in para. [0115-0116], the impermeable membrane 871 is disposed around rolled cellular material 867).
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 impermeable barrier of Figs. 23-25 with the first and second porous walls 213, 227 of Figs. 1-5 since Johnson teaches that the first and second porous walls 213, 227 are not removed from the patient’s body following use of the reduced pressure apparatus (see para. [0072]) that is used in Fig. 25. Johnson further teaches that Figs. 1-5 and 23-25 depict the reduced pressure delivery apparatus (see para. [0014, 0016, and 0038]) and discloses multiple embodiments in a single disclosure, therefore, it would be with the skill of one skilled in the art to look to the embodiments disclosed by Johnson to solve various problems or provide additional functionality to the base device.
Regarding claim 25, Johnson teaches the invention as discussed above in claim 24. Additionally, Johnson teaches wherein the barrier layer is comprised of a non-porous material (para. [0115-0116] teach in impermeable layer, therefore, it is non-porous).
Regarding claim 26, Johnson teaches the invention as discussed above in claim 25. Additionally, Johnson teaches wherein the non-porous material is liquid impermeable and hydrophobic (see para. [0115-0116]).
Regarding claim 27, Johnson teaches the invention as discussed above in claim 22. Additionally, Johnson teaches wherein the apparatus has an insertion end (as shown in Fig. 25, an insertion end is at numeral 821) and an external end (as shown in Fig. 25, an external end is at numeral 811), the external end further comprising an external barrier layer (see inner space 873 in Figs. 23-25) positioned substantially concentric about the second porous wall (as shown in Fig. 23 and as described in para. [0115-0116], the impermeable membrane 871 is disposed around rolled cellular material 867; see also claim 24 above), wherein the external barrier layer is comprised of a non-porous liquid impermeable material (inner space 873 is considered impermeable since it is part of impermeable membrane 871; see para. [0114]).
Regarding claim 30, Johnson teaches the invention as discussed above in claim 29. Additionally, in a separate embodiment, Johnson teaches further comprising a barrier layer (see impermeable membrane 871 in Figs. 23-25A) between the first circumferential wall and the second circumferential wall (as shown in Fig. 23 and as described in para. [0115-0116], the impermeable membrane 871 is disposed around rolled cellular material 867).
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 impermeable barrier of Figs. 23-25 with the first and second porous walls 213, 227 of Figs. 1-5 since Johnson teaches that the first and second porous walls 213, 227 are not removed from the patient’s body following use of the reduced pressure apparatus (see para. [0072]) that is used in Fig. 25. Johnson further teaches that Figs. 1-5 and 23-25 depict the reduced pressure delivery apparatus (see para. [0014, 0016, and 0038]) and discloses multiple embodiments in a single disclosure, therefore, it would be with the skill of one skilled in the art to look to the embodiments disclosed by Johnson to solve various problems or provide additional functionality to the base device.
Regarding claim 31, Johnson teaches the invention as discussed above in claim 30. Additionally, Johnson teaches wherein the barrier layer is comprised of a non-porous material (para. [0115-0116] teach in impermeable layer, therefore, it is non-porous).
Regarding claim 32, Johnson teaches the invention as discussed above in claim 29. Additionally, Johnson teaches wherein the apparatus has an insertion end (as shown in Fig. 25, an insertion end is at numeral 821) and an external end (as shown in Fig. 25, an external end is at numeral 811), the external end further comprising an external barrier layer (see inner space 873 in Figs. 23-25) around the second circumferential wall (as shown in Fig. 23 and as described in para. [0115-0116], the impermeable membrane 871 is disposed around rolled cellular material 867; see also claim 30 above), wherein the external barrier layer is comprised of a non-porous, liquid impermeable material (inner space 873 is considered impermeable since it is part of impermeable membrane 871; see para. [0114]).
Claims 34-41 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Johnson (U.S. Pre Grant Pub. No. 2007/0218101 A1) in view of Hardman (U.S. Pre Grant Pub. No. 2010/0106115 A1).
Regarding claim 34, Johnson teaches A system for treating a tissue site (see at least para. [0007]), comprising:
a manifold (see manifold 211 in Figs. 1-5 and para. [0069]) configured to be positioned proximate the tissue site (see para. [0069]);
a porous conduit (see rolled cellular material 865 in Fig. 23 and para. [0113-0114]) configured to be disposed in the sealed space in fluid communication with the manifold (see Fig. 23 and para. [0113-0114]), comprising:
a lumen (see tube 869 in Fig. 23),
a first barrier layer (see impermeable membrane 871 in Figs. 23-25A) extending around the first circumferential wall (as shown in Fig. 23 and as described in para. [0115-0116], the impermeable membrane 871 is disposed around rolled cellular material 867), the first barrier layer comprising a non-porous material (para. [0115-0116] teach in impermeable layer, therefore, it is non-porous); and
a therapy device adapted to be in fluid communication with the porous conduit (see reduced pressure delivery apparatus 861 in para. [0113]), the therapy device comprising a reduced-pressure source configured to be in fluid communication with the lumen (see para. [0114]).
In a separate embodiment, Johnson teaches: a first circumferential wall extending around the lumen, the first circumferential wall having a porous structure, the first circumferential wall in fluid communication with the lumen (see flexible barrier 213 in Figs. 1-5 and para. [0069-0070]; additionally, para. [0071] teaches that the barrier can be permeable to liquids, air, or other gases).
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 impermeable barrier of Figs. 23-25 with the first circumferential wall 213 of Figs. 1-5 since Johnson teaches that the first circumferential wall 213 is not removed from the patient’s body following use of the reduced pressure apparatus (see para. [0072]) that is used in Fig. 25. Johnson further teaches that Figs. 1-5 and 23-25 depict the reduced pressure delivery apparatus (see para. [0014, 0016, and 0038]) and discloses multiple embodiments in a single disclosure, therefore, it would be with the skill of one skilled in the art to look to the embodiments disclosed by Johnson to solve various problems or provide additional functionality to the base device.
However, Johnson fails to explicitly teach a cover layer configured to cover the manifold and the tissue site to provide a sealed space between the cover layer and the tissue site, as required by the claim.
Hardman teaches an analogous system for treating a tissue site (see Abstract) comprising a cover layer (see sealing member 124 in para. [0026]) configured to cover the manifold and the tissue site to provide a sealed space between the cover layer and the tissue site (see at least para. [0029-0030]).
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 Johnson to incorporate the teachings of Hardman by including a cover layer at least in order to provide a pneumatic seal adequate for open-cavity that is used to secure the manifold, as taught by Hardman (see para. [0029]).
Regarding claim 35, Johnson in view of Hardman teaches the invention as discussed above in claim 34. Additionally, Johnson teaches wherein the manifold is adapted to distribute reduced pressure to the tissue site (see para. [0007-0008]), and wherein the manifold is comprised of a porous, hydrophobic foam (see at least para. [0065-0066]).
Regarding claim 36, Johnson in view of Hardman teaches the invention as discussed above in claim 34. Additionally, Johnson teaches wherein the porous conduit has an insertion end positioned within the sealed space (as shown in Fig. 25, an insertion end is at numeral 821) and an external end positioned exterior to the sealed space (as shown in Fig. 25, an external end is at numeral 811), the external end coupled in fluid communication to the therapy device (the external end of the rolled cellular material 865 is coupled in fluid communication via reduced pressure delivery tube 869 to the reduced pressure apparatus 861; see para. [0114]).
However, Johnson fails to explicitly teach communication with a sealed space, as required by the claim.
Hardman teaches a sealing member 124 which drapes over the body cavity opening 126 and secures the manifold 122 (see para. [0029] and Fig. 1A) forming a sealed space under it (see para. [0011]).
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 Johnson in view of Hardman to further incorporate the teachings of Hardman by making the device of Johnson in view of Hardman communicate with the sealed space at least in order to provide a pneumatic seal adequate for open-cavity that is used to secure the manifold, as taught by Hardman (see para. [0029]).
Regarding claim 37, Johnson in view of Hardman teaches the invention as discussed above in claim 34. Additionally, Johnson teaches further comprising a second circumferential wall (see flexible backing 227 in Figs. 4A-B) extending around the first barrier layer (as broadly recited, Figs. 4A-B show that the flexible backing 227 extends around the flexible barrier 213), the second circumferential wall having a porous structure (para. [0071] teaches that the barrier can be permeable to liquids, air, or other gases).
Regarding claim 38, Johnson in view of Hardman teaches the invention as discussed above in claim 37. Additionally, Johnson teaches wherein the therapy device further comprises a pressure sensor (see para. [0100]) configured to be in fluid communication with the second circumferential wall (see para. [0100]).
Regarding claim 39, Johnson in view of Hardman teaches the invention as discussed above in claim 37. Additionally, Johnson teaches wherein the porous conduit has an insertion end positioned within the sealed space (as shown in Fig. 25, an insertion end is at numeral 821) and an external end positioned exterior to the sealed space (as shown in Fig. 25, an external end is at numeral 811), the external end coupled in fluid communication to the therapy device (the external end of the rolled cellular material 865 is coupled in fluid communication via reduced pressure delivery tube 869 to the reduced pressure apparatus 861; see para. [0114]).
However, Johnson fails to explicitly teach communication with a sealed space, as required by the claim.
Hardman teaches a sealing member 124 which drapes over the body cavity opening 126 and secures the manifold 122 (see para. [0029] and Fig. 1A) forming a sealed space under it (see para. [0011]).
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 Johnson in view of Hardman to further incorporate the teachings of Hardman by making the device of Johnson in view of Hardman communicate with the sealed space at least in order to provide a pneumatic seal adequate for open-cavity that is used to secure the manifold, as taught by Hardman (see para. [0029]).
Regarding claim 40, Johnson in view of Hardman teaches the invention as discussed above in claim 39. Additionally, Johnson teaches wherein the external end further comprises a second barrier layer (see inner space 873 in Figs. 23-25) extending around the second circumferential wall (as shown in Fig. 23 and as described in para. [0115-0116], the impermeable membrane 871 is disposed around rolled cellular material 867), wherein the second barrier layer is comprised of a non-porous, liquid impermeable material (inner space 873 is considered impermeable since it is part of impermeable membrane 871; see para. [0114]).
Regarding claim 41, Johnson in view of Hardman teaches the invention as discussed above in claim 34. Additionally, Johnson teaches 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 (para. [0115-0116] and Fig. 24 teach that the rolled cellular material 865 has a plurality of longitudinal depressions for radiopaque material 881 and protrusions for tube 869 disposed about an external circumference extending lengthwise).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cornet (U.S. Pre Grant Pub. No. 2011/0270301 A1) - SYSTEM AND METHOD FOR SEALING AN INCISIONAL WOUND
Tout (U.S. Pre Grant Pub. No. 2013/0123723 A1) - REDUCED-PRESSURE, TUNNEL-WOUND DRESSINGS, SYSTEMS, AND METHODS
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/CATHARINE L ANDERSON/ Primary Examiner, Art Unit 3781