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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
-Fig. 10, element 372 is mentioned in the specification but not shown in the drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because
-The abstract recites phrases such as “can include”, “can be configured”, and “can be external”. Examiner recommends amending these to –includes--, --is configured—and –is external—to include positive recitation phrasing.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
-[0004] recites “as enclosure” should possibly be –an enclosure—
-[0004] recites “movement form” should possibly be –movement from—
-[0004] recites “personnel form” should possibly be –personnel from—
-[00223] recites “for he viewing” should possibly be –for the viewing—
-[00271] recites “the can” should possibly be –this can—
-[00282] recites “pmticulate dispersion” should possibly be –particulate dispersion—
-[00304] recites “srn-geries for rn·gent” should possibly be –surgeries for urgent—
-[00304] recites “testin g,4” should possibly read –testing—
-[00320] recites “OtoSheild” should possibly read –OtoShield—
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 9, 10, 11, 12, 13, 14, 16, 17, 19 are objected to because of the following informalities:
-Claim 1 recites “space;” in line 8. Examiner recommends amending to –space; and—
-Claim 1 recites “the barrier is configured” in line 12. Examiner recommends amending to –wherein the barrier is configured—
-Claims 9, 10, 11 recites “within” in line 1. Examiner recommends amending to –of—
-Claim 12 recites “portion configured” in line 2. Examiner recommends amending to –portion being configured—
-Claim 13 recites “sleeve configured” in lines 2-3. Examiner recommends amending to –sleeve being configured—
-Claim 14 recites “mitigating…movement from the interior volume and interior the exterior space” in line 12. Examiner recommends amending to –mitigating…movement from the interior volume to the exterior space—
-Claim 16 recites “includes and an” in line 1. Examiner recommends amending to –includes an—
-Claim 17 recites “removable coupled” in line 1. Examiner recommends amending to –removably coupled—
-Claim 19 recites “received though” in lines 5 and 6. Examiner recommends amending to –received through—
Appropriate correction is required.
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 1-20 are 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.
-Claim 1 recites “the flow path of the fluid” in line 7. There is insufficient antecedent basis for this limitation in the claim.
-Claim 1 recites “mitigating…exterior space” in lines 6-8. It is unclear from this recitation what this limitation requires. Further clarification should be provided to define whether this is describing directing fluid movement from inside the system to the exterior space of the system, controlling fluid movement within the interior volume of the system, reduction of fluid movement within a portion of the system or a separate embodiment.
-Claim 1 recites “the study” in line 11. There is insufficient antecedent basis for this limitation in the claim.
-Claim 1 recites “the laboratory sample arranged in the interior volume” in line 11. There is insufficient antecedent basis for this limitation in the claim.
-Claim 1 recites “a procedure” in line 14. It is unclear whether this is the same or different from “a procedure” originally referenced in claim 1, line 2.
-Claim 1 recites “if the personnel perform a procedure on the patient” in line 14-15. It is unclear if this limitation is required by the claim and whether this limitation is intended to be actively recited. Further clarification should be provided to identify whether the barrier being positioned external to the patient is required by the claim.
-Claim 2 recites “a portion of a patient” in line 2. It is unclear whether this is the same or different from “a portion of the patient” originally referenced in claim 1, lines 12-13.
-Claim 2 recites “to enclose…sample or a structure” in line 3. It is unclear what is referenced by this limitation. Further clarification should be provided to identify whether this is referencing an additional structure separate from the system described, a structure related to the laboratory sample or patient, a structure related to the system described or a separate embodiment.
-Claim 3 recites “a patient” in line 2. It is unclear whether this is the same or different from “a patient” originally referenced in claim 1, line 1.
-Claim 3 recites “couples to…sample or the structure” in line 2. It is unclear what is referenced by this limitation. Further clarification should be provided to identify whether this is referencing an additional structure separate from the system described, a structure related to the laboratory sample or patient, a structure related to the system described or a separate embodiment.
-Claim 4 recites “the first surface of the barrier” in line 3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 7 recites “an interior volume of the barrier” in line 2. It is unclear whether this is the same or different from “an interior volume” originally referenced in claim 1, lines 4-5.
-Claim 7 recites “the exterior surface of the barrier” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Should possibly read –the exterior surface of the flange—
-Claim 11 recites “a given support beam” in line 1. It is unclear what is being referenced by this limitation. Further clarification should be provided to define whether this is a specific support beam, any one of the plurality of support beams or a separate embodiment.
-Claim 13 recites “the interior surface” in line 2. There is insufficient antecedent basis for this limitation in the claim.
-Claim 13 recites “coupled to at least one…barrier” in lines 1-2. It is unclear whether this limitation requires that the sleeve be coupled to at least one portion of each of the interior and exterior or whether the sleeve is to be coupled to one of the interior or the exterior. Further clarification should be provided.
-Claim 14 recites “mitigates…exterior space” in lines 9-12. It is unclear from this recitation what this limitation requires. Further clarification should be provided to define whether this is describing directing fluid movement from inside the system to the exterior space of the system, controlling fluid movement within the interior volume of the system, reduction of fluid movement within a portion of the system or a separate embodiment.
-Claim 18 recites “at least one of a hook and a loop fastener” in lines 1-2. It is unclear whether this is stating that one pair of hook and loop fasteners is required by this limitation or whether one of a hook or a loop fastener is required. Further clarification should be provided.
-Claim 19 recites “a portion of the first edge” in line 4. It is unclear whether this is the same or different from “a portion of the first edge” originally recited in claim 19, line 2.
-Claim 19 recites “the scaffolding” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2 and 3 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 2 recites “flange that extends along and engages with a portion of a patient” in line 3 which is directed towards human subject matter. Examiner recommends amending to –flange configured to extend along and engage with a portion of a patient—
Claim 3 recites “couples to the portion of a patient” in line 2. Examiner recommends amending to –configured to couple to the portion of a patient—
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.
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.
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:
Claim(s) 1, 2, 3, 4, 5, 6, 7, 8, 10, 11, 12, 14, 15, 16, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kriek (U.S. 20080041399).
Regarding Claim 1, Kriek teaches a system for enclosing and separating one of a patient from personnel while the personnel perform a procedure on the patient, [0037; “In order to perform a surgical procedure, the surgeon must also, of course, have access to the sterile operating enclosure”] or a laboratory sample from a technician while studying the laboratory sample, (limitation not required the system comprising: a barrier configured to form a three-dimensional (3D) structure to define an interior volume and an exterior space [Fig. 1, element 1 (enclosure)] and [0018]—describes the sterile environment within the enclosure, the interconnected region, and the external environment
and to mitigate fluid movement from the interior volume and into the exterior space thereby mitigating droplet, particulate, and aerosol movement in the flow path of the fluid from the interior volume and into the exterior space; [0009]—includes description of fluid evaporation control inside the enclosure and [0072]—reference to the personnel providing fluids into and exiting the enclosure.
a plurality of passages extending through the barrier to provide access from the exterior space and into the interior volume to perform the procedure on the patient or perform the study on the laboratory sample arranged in the interior volume, [Fig. 1, element 4 (entrance/exit ports)] the barrier is configured to be formed in the 3D structure to arrange a portion of the patient or the laboratory sample in the interior volume, and the barrier is positioned external to the patient if the personnel perform a procedure on the patient [0037] and [Fig. 1, element 2 (patient)].
Regarding Claim 2, Kriek teaches wherein a free end of the barrier includes a flange that extends along and engages with a portion of a patient or the laboratory sample to enclose the patient or the laboratory sample or a structure [Fig. 10, element 32 (flange portion)] and [0083]—references the flange portion in relation to a peripheral enclosure (element 6) which in [0082] discusses the removal of patient organs by means of elements 6 and 32 which is interpreted to include engagement with a portion of a patient.
Regarding Claim 3, Kriek teaches wherein the flange includes a coupling layer that couples to the portion of a patient or the laboratory sample or the structure [0081]—discuses a joining area comprised of layer 31 and [0082]—where the joining laying includes an adhesive.
Regarding Claim 4, Kriek teaches wherein the flange has a first surface and a second surface, and wherein the coupling layer is coupled to the first surface of the barrier [Fig. 10, elements 31 (sterilising layer-first surface) and 30 (protective layer-second surface)] and [0081; “The peripheral enclosure 6 may then be joined to the operating enclosure 1 in the region of the sterilising layer 31.”]
Regarding Claim 5, Kriek teaches wherein the coupling layer includes an adhesive [0082].
Regarding Claim 6, Kriek teaches further comprising a support structure that maintains at least a portion of the 3D structure [0067; “The enclosure 1 may be maintained in its expanded state by maintaining the pressure of the gas inside the enclosure 1 above atmospheric pressure and/or by a support frame.”]
Regarding Claim 7, Kriek teaches wherein the support structure includes a scaffold that is coupled to an interior volume of the barrier, coupled to the exterior surface of the barrier, or integrated within the barrier [0069; “In these embodiments rigid support rods 15 (as shown in FIG. 3C) are provided on the side portions 12 of the enclosure 1 and may be interconnected after inflation to provide a support frame for the enclosure 1.”]—the scaffold is interpreted to be made up of the support rods as described.
Regarding Claim 8, Kriek teaches wherein the scaffold includes a plurality of support beams [Fig. 3C, elements 15 (support rods)].
Regarding Claim 10, Kriek teaches wherein two adjacent support beams within the plurality of support beams are separated along an axial axis of the 3D structure. See annotated Fig. 3C below where separation of two adjacent support rods along an axial axis is shown.
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Regarding Claim 11, Kriek teaches wherein a given support beam within the plurality of support beams is coupled to the two adjacent support beams. See annotated Fig. 3C below.
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Regarding Claim 12, Kriek teaches wherein the given support beam includes a resilient portion, the resilient portion configured to bend to allow the given support beam to be folded or shaped [0065] and [Fig. 3F, element 12 (side portions)].
Regarding Claim 14, Kriek teaches wherein the barrier includes: a central region; [0062]—reference to a flexible membrane, a first region with a first free end extending from the central region, [Fig. 3D, element 10 (upper portion)] the first region having a first edge; [0010]—introduces the edges of the membrane and outside and inside surfaces of the membrane, and a second region with a second free end extending from the central region, , [Fig. 3D, element 12 (side portion)] the second region having a second edge, [0010] and wherein the first edge of the first region is configured to be coupled to the second edge of the second region to join the first region to the second region, [Fig. 3D, element 17 (attachment region)] and wherein coupling of the first edge to the second edge provides an adjoined edge of the barrier that mitigates fluid movement from the interior volume and into the exterior space along the adjoined edge thereby mitigating droplet, particulate, and aerosol movement from the interior volume and interior the exterior space along the adjoined edge [Fig. 3D, element 16 (peripheral attachment)] and [0009]—which describes controlling fluid evaporation which would encompass droplet, particulate and aerosol movement about the enclosure.
Regarding Claim 15, Kriek teaches wherein the first edge of the first region includes a strip that extends along a portion of the first edge [0019]—discloses an adhesive provided on the end wall member (interpreted to be the upper portion/first region).
Regarding Claim 16, Kriek teaches wherein the strip includes and an adhesive layer configured to be secured to a surface of the second region [0019].
Regarding Claim 17, Kriek teaches wherein the strip is removable coupled to a surface of the second region [0062]—reference to the attachment means as intermittent which is interpreted to include removal of the attachment.
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.
Claim(s) 9, 13, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kriek (U.S. 20080041399) in view of Petersen (U.S. 20200179219).
Regarding Claim 9, Kriek is silent on wherein a first support beam within the plurality of support beams is curved. Petersen teaches wherein a first support beam within the plurality of support beams is curved. [Fig. 1, element 104 (arches)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide curved support members as taught by Petersen to establish a curved shape of the structure and structural components as suggested by Kriek, as Kriek discusses using curved window panels [0069] with Petersen because Petersen teaches the use or arches and rods to fit together to support a frame that allows for variations in the framework [0042].
Regarding Claim 13, Kriek is silent on further comprising a sleeve coupled to at least one of the interior surface and the exterior surface of the barrier, the sleeve configured to receive a support beam. Petersen teaches further comprising a sleeve coupled to at least one of the interior surface and the exterior surface of the barrier, the sleeve configured to receive a support beam [0057; “ In some embodiments, fastening mechanism may include sleeve 704 to further reduce movement of rod 406 … sleeve 704 may be positioned such that the distance between cap 702 and sleeve 704 is the width of arch 404.”] –in this interpretation, the sleeve is considered to be couple to at least one of the interior surface with mention of the sleeve being placed between the cap and width of arch.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a sleeve or covering as taught by Petersen to establish and secure a support member to the structure as suggested by Kriek, as Kriek discusses mounting support members to the flexible membrane and supporting frame [0010] with Petersen because Petersen teaches the use sleeves as a fastening mechanism to reduce movement of the support rods [0057].
Regarding Claim 18, Kriek is silent on wherein the strip includes at least one of a hook and a loop fastener, and the surface of the second region includes the other of the at least one of the hook and the loop fastener. Petersen teaches wherein the strip includes at least one of a hook and a loop fastener, and the surface of the second region includes the other of the at least one of the hook and the loop fastener [0069]—flexible cover includes coupling mechanisms such as Velcro.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include Velcro to secure portions of the structure together as taught by Petersen to allow for deconstruction of the structure by means of folding and collapsing by Kriek, as Kriek discusses the collapsible nature of the structure [0013] with Petersen because Petersen teaches quickly undoing the fastening means to remove the cover from the frame [0069].
Claim(s) 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kriek (U.S. 20080041399) in view of Petersen (U.S. 20200179219) and in further view of Hardin (U.S. 9038214).
Regarding Claim 19, Kriek and Petersen are silent on wherein the first edge of the first region includes a first sleeve that extends along a portion of the first edge, and wherein the second edge of the second region includes a second sleeve that extends along a portion of the first edge, and wherein the scaffolding includes a support beam that is received though the first sleeve and though the second sleeve to couple the first region to the second region. Hardin teaches wherein the first edge of the first region includes a first sleeve that extends along a portion of the first edge, and wherein the second edge of the second region includes a second sleeve that extends along a portion of the first edge, [Fig. 15, elements 418 (first sleeve), 420 (second sleeve)] and wherein the scaffolding includes a support beam that is received though the first sleeve and though the second sleeve to couple the first region to the second region [Fig. 15, element 436, 438 (grommet-reinforced aperture)] and [Col 14, lines 8-14; “grommet-reinforced aperture…coupled to first and second end sleeves”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide two sleeves on opposing surfaces of the support structure as taught by Hardin to establish and secure a support member to the structure as suggested by Kriek, and Petersen as Kriek discusses mounting support members to the flexible membrane and supporting frame [0010] and Petersen which discloses the use of sleeves to reduce movement of support rods [0057] with Hardin because Hardin teaches the sleeves allowing for expansion and collapse of the structure [Col 13, lines 15-17].
Regarding Claim 20, Kriek and Petersen are silent on wherein the first sleeve is positioned above the second sleeve. Hardin teaches wherein the first sleeve is positioned above the second sleeve [Fig. 15, elements 418 (first sleeve), 420 (second sleeve)] and [Fig. 9]—reference to the gurney being positioned to a lifted configuration where the first sleeve would be located above the second sleeve in the inclined position.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide two sleeves with one sleeve above the other as taught by Hardin to establish and secure a support member to the structure as suggested by Kriek, and Petersen as Kriek discusses mounting support members to the flexible membrane and supporting frame [0010] and Petersen which discloses the use of sleeves to reduce movement of support rods [0057] with Hardin because Hardin teaches the sleeves allowing for expansion and collapse of the structure [Col 13, lines 15-17].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Sung (WO 2021215586)—includes an isolator unit comprised of a cover and frame to prevent spread of droplets
-Maloney (U.S. 20090093671)-describes a mobile isolation unit with a foldable frame
-Rees (U.S. 20160317110)-includes disclosure of hook-and-fastener element.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at 571-272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791