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 .
Status of Claims
Claims 1-5, 8-15, 20, 23-25, 27, 30-31, and 89 are pending and currently under consideration for patentability.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Response to Arguments
Applicant’s arguments, see pages 6-12, filed 2/23/2026, with respect to the rejection(s) of claim(s) 1-5, 8-15, 20, 23-25, 27, 30-31, and 89 under 35 USC § 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 Therefore, the rejection has been withdrawn.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 Locke (WO 2018094061 A1) but different embodiments.
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.
Claim(s) 1-2, 9-15, 20, 30-31, and 89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke (WO 2018094061 A1) in view of Johannison (US 20130261541 A1).
Regarding Claim 1, Locke teaches a fluid bridge (124) for delivering negative-pressure to a tissue site (paragraph 0053)(figures 1 and 2), comprising:
a first encapsulating member (sealing, 140) comprising a polymer film (paragraph 0075) of liquid-impermeable material (paragraph [0075-0076]); and
a second encapsulating member (extension of 164, paragraph 0074, “The sealing member 140 may cover the tissue site 104 and the interface manifold 120 to provide a fluid seal and a sealed space 174 between the tissue site 104 and the sealing member 140 of the dressing 124.“) comprising a polymer film of liquid impermeable material, a periphery of the first encapsulating member (140) coupled to a periphery of the second encapsulating member to form (figure 8, coupled with adhesive 136, paragraph [0061]).
However, Locke fails to teach that the open-cell foam has a density in a range of about 2.6-8.0 lb/ft3 and a free volume in a range of about 18% to about 45%. Johannison teaches a wound care treatment apparatus the open-cell foam has a density in a range of about 2.6-8.0 lb/ft3 (converted from 110-130 kg/m3)(paragraph [0046]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the density of Locke to have the density of Johannison to comply with ISO 845 (paragraph [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a free volume in a range of about 18% to about 45% in order to fit the particular procedure being done since this claimed dimension of the free volume can change depending on the needed pores/inch. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0011 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the support manifold configured to maintain a fluid pathway through the envelope while subjected to a compression garment applying between about 20 mmHg and about 60 mmHg compression in order to fit the particular procedure being done since this claimed dimension of the non-critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0012 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 2, Locke in view of Johannison teaches a fluid bridge of claim 1, wherein: the envelope (132) comprises a first surface (exterior of 132) and a second surface (Interior of 132);
the support manifold (120) comprises a first end (left side of figure 8) and a second endl right side of figure 8
and the envelope further comprises a first aperture (160) located on the first surface (152) in proximity to the first end (see annotated figure 4a) and a second aperture (160) located on the second surface (156) in proximity to the second end (annotated figure 4a).
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Regarding Claim 9, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke fails to explicitly teach wherein the open-cell foam of the support manifold has a density of about 3.9-4.8 lb/ft3. Johannison teaches that Granufoam has a pre-felt density of 1.3-1.6 lb/ft. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to change the manifold to a density in a range of about 3.9-4.8 lb/ft3 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to increase the density of the open-cell foam so that more fluid may be absorbed by the bridge.
Regarding Claim 10, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke fails to explicitly teach wherein the open-cell foam of the support manifold has an average pore size of about 133-200 micron. Granufoam is known in the art for having an open pore size of 400-600 microns. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to change the size of the pores to 133-200 microns, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to reduce the pore size so that less solid and less debris may enter the pores.
Regarding Claim 11, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke and Johannison fail to explicitly teach wherein the open-cell foam of the support manifold has 120-150 pores per inch on average. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the open cell foam so there are 120-150 pores per inch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to increase pores per inch to increase absorption of the sponge.
Regarding Claim 12, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke and Johannison fail to explicitly teach wherein the open-cell foam of the support manifold has 120-135 pores per inch on average. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the open cell foam so there are 120-135 pores per inch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to increase pores per inch to increase absorption of the sponge.
Regarding Claim 13, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke and Johannison fail to explicitly teach wherein the open-cell foam of the support manifold has a 25% compression load deflection of at least 1.05 pounds per square inch and a 65% compression load deflection of at least 1.29 pounds per square inch. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the open cell foam so it has a 25% compression load deflection of at least 1.05 pounds per square inch and a 65% compression load deflection of at least 1.29, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to have a large compression load so that the support manifold may support more weight so more fluid may be absorbed.
Regarding Claim 14, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke and Johannison fails to explicitly teach wherein the open-cell foam of the support manifold has a 25% compression load deflection of at least 1.75 pounds per square inch and a 65% compression load deflection of at least 2.15 pounds per square inch. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the open cell foam so it has a 25% compression load deflection of at least 1.75 pounds per square inch and a 65% compression load deflection of at least 2.15, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to have a large compression load so that the support manifold may support more weight so more fluid may be absorbed.
Regarding Claim 15, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke and Johannison fail to explicitly teach wherein the open-cell foam of the support manifold has a 25% compression load deflection in a range of about 1.05-1.75 pounds per square inch and a 65% compression load deflection in a range of about 1.29-2.15 pounds per square inch. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the open cell foam so it has a 25% compression load deflection of at least 1.05-1.75 pounds per square inch and a 65% compression load deflection in a range of about 1.29-2.15, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to have a large compression load so that the support manifold may support more weight so more fluid may be absorbed.
Regarding Claim 20, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke and Johannison fail to teach wherein the bridge has a length at least 15 times greater than the width. Locke shows that the length and width of the bridge is a result effective variable, Locke shows that the dimensions may vary to better cover the particular wound in question as shown in the specification of Locke (paragraph [0083]). It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the bridge so it has a length at least 15 times greater than the width, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding Claim 30, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke and Johannison fail to teach wherein the envelope comprises a perforation providing controlled flow of less than about 5cc/min located in proximity to the second end. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the envelope so it comprises a perforation providing controlled flow of less than about 5cc/min located in proximity to the second end, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to have a flow rate of less than 5cc/min so that more fluid has a chance to absorb in in the bridge.
Regarding Claim 31, Locke in view of Johannison teaches the fluid bridge of claim 1. Locke further teaches a hydrophilic layer (132) adjacent to the support manifold (120) within the envelope (figure 1) (paragraph 0065).
Regarding Claim 89, Locke in view of Johannison teaches the fluid bridge of claim 1. Locke further teaches a wicking layer coupled to an exterior of the envelope (paragraph [0021][0076]).
Claim(s) 3-5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Locke (WO 2018094061 A1) in view of Johannison (US 20130261541 A1) in view of Ingram (US 20180153570 A1).
Regarding Claim 3, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke fails to explicitly teach wherein the support manifold comprises a thickness of at least 5 mm. However Locke does teach the manifold is compressed or felted Granufoam (paragraph 0059). Ingram teaches a thickness of 4-15 mm for compressed Granufoam (paragraph 0066). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the thickness of the manifold of Locke to a thickness of 5 mm similar to that disclosed by Ingram as Granufoam is known in the art to be compressed to 5 mm.
Regarding Claim 4, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke and Johannison fail to explicitly teach wherein the open-cell foam has about 80-250 pores per inch on average. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the open cell foam so there are 80-250 pores per inch, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to increase pores per inch to increase absorption of the sponge.
Regarding Claim 5, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke fails to explicitly teach wherein the open-cell foam has an average pore size of about 80-300 micron. Ingram teaches Granufoam is known in the art for having a pore size of less than 600 microns (paragraph 0080). It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to change the size of the pores to 80-300 microns, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would be motivated to reduce the pore size so that less solid and less debris may enter the pores.
Regarding Claim 8, Locke in view of Johannison and Pratt teaches a fluid bridge of claim 1. Locke fails to explicitly teach wherein the support manifold comprises a thickness of at least 5-7 mm. However Locke does teach the manifold is compressed or felted Granufoam (paragraph 0065). Ingram teaches a thickness of 4-15 mm for compressed Granufoam (paragraph 0066). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the thickness of the manifold of Locke to a thickness of 5-7 mm similar to that disclosed by Ingram as Granufoam is known in the art to be compressed to 5-7 mm.
Claim(s) 23-25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke (WO 2018212849 A1) in view of Johannison (US 20130261541 A1) as applied to claim 1 above, and further view of Locke (US 20200268561 A1).
Regarding Claim 23, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke further teaches wherein the support manifold is configured so that a negative-pressure drop across the length of the fluid bridge when in substantially vertical orientation (paragraph 0088). Locke and Johannison fail to teach wherein the support manifold is configured so that a negative-pressure drop across the length of the fluid bridge is no more than about 50 mmHg. Locke (US 20200268561 A1) teaches fluid bridge (145) may be fluidly coupled to the dressing (110), if appropriate, and the fluid bridge (145) may be fluidly coupled to the negative-pressure source (105) (paragraph 0077) with a pressure drop over the period that was generally less than 25 mmHg (paragraph 0085). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the fluid bridge or Locke in view of Johannison to include a fluid drop of less than 50 mmHg similar to that disclosed by Locke (US 20200268561 A1) so that significant pressure is maintained across the bridge.
Regarding Claim 24, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke and Johannison fails to explicitly teach wherein the fluid bridge is configured so that a negative-pressure drop across a length of the bridge is less than 60 mmHg when the bridge is in a vertical orientation. Locke ( US 20200268561 A1) teaches fluid bridge (145) may be fluidly coupled to the dressing (110), if appropriate, and the fluid bridge (145) may be fluidly coupled to the negative-pressure source (105) (paragraph 0077) with a pressure drop over the period that was generally less than 25 mmHg (paragraph 0085). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the fluid bridge or Locke in view of Johannison to include a fluid drop of less than 60 mmHg similar to that disclosed by Locke (US 20200268561 A1) so that significant pressure is maintained across the bridge.
Regarding Claim 25, Locke in view of Johannison teaches a fluid bridge of claim 1. Locke and Johannison fail to explicitly teach wherein the fluid bridge is configured so that a negative-pressure drop across a length of the bridge is less than 75 mmHg when the bridge is in a vertical orientation and under compression. Locke ( US 20200268561 A1) teaches fluid bridge (145) may be fluidly coupled to the dressing (110), if appropriate, and the fluid bridge (145) may be fluidly coupled to the negative-pressure source (105) (paragraph 0077) with a pressure drop over the period that was generally less than 25 mmHg (paragraph 0085). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the fluid bridge or Locke in view of Johannison to include a fluid drop of less than 75 mmHg similar to that disclosed by Locke (US 20200268561 A1) so that significant pressure is maintained across the bridge.
Regarding Claim 27, Locke in view of Johannison teaches a fluid bridge of claim 2. Locke and Ingrim fail to teach, wherein the fluid bridge is configured to maintain, when used in a vertical orientation and under compression, at least 75 mmHg negative pressure at the second aperture when 125 mmHg negative pressure is applied to the first aperture. Locke (US 20200268561 A1) teaches fluid bridge (145) may be fluidly coupled to the dressing (110), if appropriate, and the fluid bridge (145) may be fluidly coupled to the negative-pressure source (105) (paragraph 0077) with a pressure drop over the period that was generally less than 25 mmHg (paragraph 0085). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the fluid bridge or Locke in view of Johannison to include a fluid drop of less than 50 mmHg similar to that disclosed by Locke (US 20200268561 A1) so that significant pressure is maintained across the bridge.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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