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 Objections
Claim 46 is objected to because of the following informalities: in line 4 of claim 46, “into” should be deleted (see attached interview summary). Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “expandable portion” in claims 46, 52, and 53; “air release mechanism” in claim 65; “guide probe” in claims 56, 57 and 58.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 46, 48-53, 55, 56, 58-60 and 62-65 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kieturakis (US 5,540,711; herein after “Kieturakis”).
Regarding claim 46, Kieturakis discloses an expandable tamponade (Figure 56) for treating penetrating wounds (capable of occluding a wound and therefore capable of acting as a tamponade device), comprising: an expandable portion (616; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s expandable portion 109); a handle mechanism (any or all components other than 616; noting that all of these components can be grasped and used as a handle to manipulate member 616 and further noting Applicant has disclosed that the movable guide probe 404 is part of the handle mechanism in claim 56) configured to insert the expandable portion into a wound, the handle mechanism comprising a strut (all of 671, or the cylindrical portion of 671; analogous to 350 in Figure 41) which is fixedly connected to (a portion of) the handle mechanism and is configured to be inserted into the wound before the expandable portion and capable of opening-up musculature of the wound (col. 30, lines 58-64; it could be inserted into the wound before it receives member 616 or while member 616 is proximal to its leading edge); and a coupling means (646) configured to couple the expandable portion to a fluid supply and configured to expand the expandable portion inside the wound (col. 28, lines 22-32).
Regarding claim 48, the expandable portion comprises a flexible outer wall (617) that defines an inner chamber (626; evident from Figure 59), wherein the inner chamber is configured to be filled with a fluid to expand the expandable portion inside the wound (col. 28, lines 22-32).
Regarding claim 49, the expandable portion comprises: a flexible outer wall (617); an inner wall (677); an inner chamber (626) between the flexible outer wall and the inner wall (626), wherein the inner chamber is configured to be filled with a fluid to expand the expandable portion inside the wound (col. 28, lines 22-32); and a channel (678) defined by the inner wall and configured to receive a guide probe or inspection probe (686/687; Figure 57B).
Regarding claims 50 and 51, Kieturakis discloses that the inner wall is fixedly connected at a first end to a portion of the handle mechanism (see unlabeled handle section through which 686 is inserted in Figure 56; the claims do not preclude certain parts of the handle mechanism from being immovable relative to others) and at a second end to a rigid locator tip (681; medical grade plastic - col. 29, lines 13-24) configured to guide the expandable portion through the wound (col. 29, line 65 to col. 30, line 2), and wherein a second end of the wall is configured to freely move within the inner chamber (676 is movable relative to all other portions of the device; col. 29, lines 59-65).
Regarding claims 52 and 53, the handle mechanism comprises a housing (remainder of 671), and wherein the housing and/or the strut is capable of containing the expandable portion before it is inserted into the wound (the skin seal 671 could be introduced into a wound with some portion of the expandable portion contained within - col. 30, lines 55-67).
Regarding claim 55, the expandable portion can be provided in the housing in a rolled, folded or wrapped state (the housing has a diameter such that the expandable portion could be provided within 671 in the state of Figure 63; col. 30, line 64 to col. 31, line 7), and/or wherein the housing comprises a first aperture and a second aperture, wherein the first aperture is configured to receive a guide probe (676 or 686) configured to push the expandable portion out of the second aperture of the housing, thereby guiding the expandable portion through the wound (col. 30, lines 3-10).
Regarding claim 56, the handle mechanism comprises a guide probe (676 or 686; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s guide probe 404) configured to guide the expandable portion into the wound (col. 30, lines 3-10).
Regarding claim 58, the guide probe is moveable within the channel (col. 29, line 58 to col. 30, line 8), such that a length of the expandable portion within a wound can be varied, preferably wherein the strut is inserted into the wound, before the expandable portion and guide probe is inserted into a wound (the guide probe can be advanced to its distal-most position within the expandable portion before they are both inserted through 671 and into a wound; the amount of the expandable portion introduced into the wound by the guide portion can then be varied), wherein the strut opens-up musculature of the wound to enable the expandable portion to be inserted into and removed from the wound (col. 30, line 55 to col. 31, line 8).
Regarding claim 59, the guide probe is removable after the expandable portion has been inserted into a wound and expanded (col. 30, line 55 to col. 31, line 8).
Regarding claim 60, the guide probe must be one of flexible or rigid.
Regarding claim 62, Kieturakis discloses a system for treating penetrating wounds comprising: at least one of the expandable tamponade (616/601) according to claim 46, and a hand-portable actuator (“syringe” - col. 28, lines 22-32); wherein the at least one of the expandable tamponade is configured so as to be capable of being received within a wound (evident from Figure 9 and elsewhere) and comprises coupling means (646) to enable the at least one of the expandable tamponade to be coupled to the hand-portable actuator; and the hand-portable actuator comprises means for expanding the expandable tamponade (“syringe” - col. 28, lines 22-32) and coupling means (648) to enable the at least one expandable tamponade to be coupled to the hand-portable actuator so as to enable expansion of the at least one expandable tamponade.
Regarding claim 63, the hand-portable actuator is any one of: a bulb air pump; an air- or liquid-filled syringe (col. 28, lines 22-32); an electric actuator; a compressed gas canister; and a mechanical actuator and/or wherein the hand-portable actuator is configured to supply any one of the following materials into the expandable portion of the at least one of the expandable tamponade: a material detectable in a medical imaging process; air; a gas; a liquid (col. 28, lines 22-32); a foam; and an expandable foam.
Regarding claim 64, the at least one of the expandable tamponade comprises an absorptive pad (182) configured to absorb blood external to a wound (a mesh would be capable of this; col. 14, lines 7-11 - “non-absorbable” being understood to mean --non-degradable--) or wherein the at least one of the expandable tamponade comprises sealing means (182 - noting that Applicant’s sealing means is a bandage) configured to, at least partially, seal a wound site.
Regarding claim 65, the at least of the one of the expandable tamponade comprises an air release mechanism (666; col. 28, lines 41-52; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s air release mechanism 143) configured to enable air to be released into an atmosphere and/or wherein the hand-portable actuator comprises control means configured to receive an input from one or more pressure sensors indicative of pressure within an expandable tamponade and configured to use an input signal from the pressure sensors to control the means for expanding the expandable tamponade.
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 disclosesd 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 non-obviousness.
Claims 47, 54 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Kieturakis (US 5,540,711).
Regarding claim 47, Kieturakis (being reasonably pertinent to Applicant’s problem of stopping blood loss using an inflatable means - e.g. see Figure 1 and ¶[0083]-[0087] of US 2005/0143689 showing that it is known in the art to use a variety of balloon catheters as a tamponade) discloses that the expandable portion is: fixedly connected, at a first end, to the handle (602 being part of the handle; col. 27, lines 53-67); and fixedly connected, at a second end, to a locator tip (631) configured to guide the expandable portion through the wound (col. 27, lines 63-67).
Kieturakis fails to disclose that the locator tip is rigid. Kieturakis discloses that a similar locator tip (930; Figure 90) in another embodiment can help prevent tearing of the expandable portion during tunneling through tissue (col. 44, lines 14-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of Figure 90 to have made the locator tip of Figure 56 from a (at least somewhat) rigid material so that it could more effectively help with tunneling of the expandable portion through tissue without allowing tearing of the expandable portion.
Regarding claim 54, with the above modification, the rigid locator tip could be made to protrude through the strut while some amount of the expandable portion is contained within the housing (671), or the rigid locator tip could be contained within the housing and/or the strut (evident from Figure 56), and the handle mechanism comprises a seal (612 or 672) that seals the strut.
Regarding claim 57, Kieturakis discloses that the strut is capable of opening-up musculature of a wound to enable the expandable portion to be removed from the wound (col. 30, line 55 to col. 31, line 7) but fail to discloses that the guide probe is fixedly provided within the channel.
Kieturakis discloses another embodiment having a tunnelling device (303; Figures 39 and 40; 676 being a tunneling device) secured to a portion of a handle mechanism (col. 18, lines 55-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have fixedly secured the guide probe or tunneling device to a portion of the handle mechanism (e.g. to 611) in order to more securely position the guide probe at its intended position within the channel (fixing the guide probe to the handle causing it to be fixed within the channel).
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Kieturakis (US 5,540,711) in view of Soares Da Costa (US 2014/0012395).
Regarding claim 61, Kieturakis fails to discloses a coating on an external surface of the expandable portion as claimed. Kieturakis discloses that the expandable portion may have a hernia patch (182; Figure 20; col. 13, line 58 to col. 14, line 40) on an external surface.
Soares Da Costa (being in Applicant’s field of wound treatment devices - Abstract) teach that a hernia patch can be loaded with an antibiotic (¶[0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Soares Da Costa to have loaded the hernia patch of Kieturakis with an antibiotic as one skilled in the art would recognize that this would prevent infection of the hernia. The patch (182) loaded with an antibiotic can be regarded as an infection mitigation compound coated on the external surface of the expandable portion of Kieturakis.
Response to Arguments
Applicant's arguments filed December 30th 2025 have been fully considered but they are not persuasive. Applicant has argued that member 671 of Kieturakis is not part of the handle assembly. Applicant has effectively disclosed in claims 56 and 58 that the movable and removable guide probe (404) is part of the handle mechanism. It is therefore reasonable to consider member 671 as part of the handle mechanism of Kieturakis. Applicant has argued that member 671 is never inserted into a wound before the expandable portion (616). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The expandable portion of Kieturakis is insertable through the proximal end of member 671. Therefore member 671 is insertable into a wound before the expandable portion. Again, it is noted that Applicant has claimed two relatively movable structures, which are not fixed in any way, as the handle mechanism in original claim 58. Applicant has argued that the strut of Kieturakis is not configured to open-up musculature of a wound. Applicant has depicted the strut as a basic cylindrical structure in at least Figures 5 and 6. It is not understood what structure the strut of Kieturakis lacks or possesses that prevents it from performing this function. Applicant has argued that the device of Kieturakis is non-analogous art. It is known in the art to use medical balloon catheters to tamponade a wound even though they were not intended to tamponade a wound. See for example ¶[0083] of US 2005/0143689. Therefore, a reference to any balloon catheter would be reasonably pertinent to the problem faced by the inventor; even if it is not in the same field of endeavor as the claimed invention (MPEP 2141.01(a)(I)).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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