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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the
-“at least one system for sterilising the incoming air and at least one pumping system for forming a laminar airflow within said device” (claim 1)
-“said device can be coupled to a headrest cushion or a seat and a neck support” (claim 2)
-“said at least one system for sterilising the incoming air consists of an air filter capable of retaining micro-organisms” (claim 6)
-“said at least one pumping system for forming a laminar airflow (3) is connected to said at least one system for sterilising the incoming air.” (claim 7)
-“said at least one pumping system for forming a laminar airflow (3) is a fan” (claim 8)
-“said at least one pumping system for forming a laminar airflow is positioned on the top sides of said device.” (claim 9)
-“activated by means of a special switch or automatically when said at least one front closable portion (1) is in closed position” (claim 10 and 11)
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 it contains the recitation “said device” in line 3. 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).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The disclosure is objected to because of the following informalities:
-Pg. 2 recites “In light of the above, object of” in line 22 and “Additionally, object” in line 29. Examiner recommends amending to “In light of the above, the object” and “Additionally, the object.”
Appropriate correction is required.
Claim Objections
Claims 1-13, 15 are objected to because of the following informalities:
-Examiner recommends cancelling the reference characters contained within the claim language.
-Claims 1-12 recites “Device adapted” or “Device according to” in line 1. Examiner recommends amending to “A device adapted” and “The device according to.”
-Claim 4 recites “at least one front closable portion” in line 2. Examiner recommends amending to “said at least one front closable portion.”
-Claim 5 recites “from closed to open configuration” in lines 3-4. Examiner recommends amending to “from a closed to an open configuration.”
-Claim 10 recites “in closed position” in line 4. Examiner recommends amending to “in a closed position.”
-Claim 11 recites “in open position” in line 4. Examiner recommends amending to “in an open position.”
-Claim 11 recites “at least one pumping system” in line 2. Examiner recommends amending to “said at least one pumping system.”
-Claim 12 recites “Device according to claim 1, wherein environment” in lines 1-2. Examiner recommends amending to “Device according to claim 1, wherein an environment.”
-Claim 12 recites “sterile already a few" in line 2. Examiner recommends cancelling the word “already.”
-Claims 13 and 15 recites “Method for” in line 1. Examiner recommends amending to “A method for.”
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “means of hinges” in claim 5 and “means of a special switch” in claims 10 and 11.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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:
-Claim 1 recites “at least one system” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is for sterilizing the incoming air. Based on the specification, there is no disclosure provided to disclose the corresponding structure. There is no sufficient structure for this limitation provided in the claims.
-Claim 1 recites “at least one pumping system” which is a generic placeholder. The function of this limitation is for forming a laminar flow. According to the specification the at least one pumping system includes [Pg. 5, lines 11-13; “the device object of the invention can be equipped with a dual ventilation system for air recycling and ejection, respectively. For example, a battery powered fan”] and equivalents thereof.
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 § 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 1-15 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 incoming air” in line 3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 4 recites “the insertion,” the operator’s hands”, “the instruments” and “the sterile operating field” in lines 3-4. There is insufficient antecedent basis for these limitations in the claim.
-Claim 5 recites “the top part” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 5 recites “its rotation” in line 3. It is unclear what structure “its” is referring to. Further clarification should be provided to identify whether this is referring to the at least one front closable portion, device, hinges, or a separate embodiment.
-Claim 8 recites “at least one pumping system for forming a laminar airflow (3) is a fan” in lines 2-3. It is unclear how a pumping system could be embodied by a fan based on the definition of pumping understood by one of ordinary skill in the art.
-Claim 9 recites “the top sides” in line 3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 10 recites “a special switch” in line 10. It is unclear what is referenced by this limitation. Special could mean various things to one of ordinary skill in the art therefore, further clarification should be provided to define the term special.
-Claim 12 recites “a few tens of seconds” in lines 2-3. It is unclear what is meant by “a few.” Further clarification should be provided.
-Claim 12 recites “after its activation” in line 3. It is unclear what “its” is referring to in terms of the claimed components of the device. Further clarification should be provided to identify whether this is referring to the at least one pumping system, the special switch, the one front closable portion or a different embodiment.
-Claim 13 recites “in heads of patients in need thereof” in line 2. It is unclear whether this recitation is referring to patients in need of surgical or para-surgical procedures or whether this is referring to a separate need. Further clarification should be provided.
-Claim 13 recites “said patients in microbiologically aseptic environments” in line 4. There is insufficient antecedent basis for this limitation in the claim.
-Claim 14 recites “the ophthalmic field” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 15 recites “operating said device” in line 4. It is unclear what is meant by the step of operating. Further clarification should be provided to further define the limitations associated with operating the device.
-Claim 15 recites “obtaining said sterile conditions” in line 5. It is unclear what is meant by the step of obtaining sterile conditions. Further clarification should be provided to further define the limitations associated with obtaining sterile conditions.
Claim limitation “at least one system for sterilising the incoming air” in claim 1 line 3 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification provides reference to HEPA and ULPA filters [Pg. 5, lines 3-6]; however, this disclosure does not fulfill the necessary function of “sterilising the incoming air.” Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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, 4, 6-8, 13, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas (U.S. 5083558).
Regarding Claim 1, Thomas teaches device adapted to create a sterile area that can be located at a subject's head level, [Col 7, lines 8-15; “The surgeon's head, which is a source of pathogens due to respiration, falling hair and the like, remains outside of the surgical compartment, and the surgeon 10 views the subject through the transparent sidewall. Preferably, the sidewall 34 is inclined, enabling the surgeon to lean slightly over the patient, and also preventing reflections of windows and the like from obscuring the view of the subject.”] and [Col 3, lines 42-45; “It is a further object of the invention to facilitate veterinary surgery on laboratory animals by providing a convenient yet sterile area in which to conduct surgical procedures on the animals.”]
said device comprising at least one front closable portion (1), [Fig. 2, element 30].
at least one system for sterilising the incoming air [Col 5, lines 36-37; “The air circulation means includes a micro pore filter, specifically a HEPA filter 96 which produces class 100 air.”]
and at least one pumping system for forming a laminar airflow within said device [Col 5, lines 44-45; “A fan 92 or similar means forces air through the filter 96.”]
Regarding Claim 4, Thomas teaches device according to claim 1. Thomas further teaches wherein at least one front closable portion (1) is transparent and provides at least one opening (2) which allows the insertion of the operator's hands and the instruments into the sterile operating field [Col 5, lines 54-59; “at least one of the sidewalls including a transparent panel for viewing an inside of the surgical compartment, the at least one of the sidewalls 34 terminating at a space from the bottom panel for manual access to the inside of the surgical compartment 24 housed through access openings 30.”]
Regarding Claim 6, Thomas teaches Device according to claim 1, wherein said at least one system for sterilising the incoming air consists of an air filter capable of retaining micro-organisms [Abstract; “Air circulation is forced through a high performance HEPA filter between an inlet including the bottom of the enclosure and an outlet at the top,”] This interpretation is based on the disclosure provided which includes HEPA filters as a means for filtering the incoming air.
Regarding Claim 7, Thomas teaches device according to claim 1. Thomas further teaches wherein said at least one pumping system for forming a laminar airflow (3) is connected to said at least one system for sterilising the incoming air [Col 5, lines 44-45] and [Col 5, lines 49-51; “Additionally or alternatively, an inlet draws air from the room into the circulation system, to be filtered, and directed downwardly into the operating field area.”]
Regarding Claim 8, Thomas teaches Device according to claim 1. Thomas further teaches wherein said at least one pumping system for forming a laminar airflow (3) is a fan [Fig. 3, element 92].
Regarding Claim 13, Thomas teaches method for carrying out surgical and para-surgical procedures in heads of patients in need thereof with the device according to claim 1. Thomas further teaches said method comprising: operating on said patients in microbiologically aseptic environment created by said device [Col 6, lines 50-54; “A portal 102 for access of the subject, as used for humans, can be dimensioned to accommodate an appendage of the subject such as an arm, leg, head, etc.”] and [Col 3, lines 11-16; “Particularly together with means defining an air curtain at the opening, the aspect of excluding outside particles provides the ability to conduct aseptic surgical technique in remote areas such as battlefields and on the site of mass casualty events.”]
Regarding Claim 14, Thomas teaches the method according to claim 13, wherein said surgical and para-surgical procedures are procedures in the ophthalmic field [Col 3, lines 46-53; “It is still another object to facilitate performance of surgical procedures on human patients (e.g., microsurgery, knee surgery, neurosurgery, ophthalmic surgery, vascular surgery, etc.) by providing a convenient yet sterile area in which to conduct the procedures, defined by a compact and mobile apparatus capable of transport to a location needed, via helicopter, ambulance, aircraft, ship, etc.”]
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) 2, 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (U.S. 5083558) in view of Manzella (U.S. 20070089221).
Regarding Claim 2, Thomas teaches device according to claim 1. Thomas is silent on wherein said device can be coupled to a headrest cushion or a seat and a neck support.
Manzella teaches wherein said device can be coupled to a headrest cushion or a seat and a neck support [0087; “Referring to FIGS. 4, 4A and 4B, the adjustable head securing assembly 400 includes: (a) a head support assembly 402 coupled to the shell unit 202 through the biasing members.”]
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 Thomas which discloses providing a configuration where clinicians have full access to the enclosure but the patient is still maximized [Cols 2-3, lines 67-7; “The surgeon(s) and assistants having full access from opposite sides of the mobile enclosure are nevertheless completely removed from the operating area, only the hands and forearms coming into the protected space. This helps to facilitate maximum patient protection by minimizing possible patient operative site contamination from the surgical team's faces, foreheads, necks, and other areas not routinely covered by traditional operating room attire.”] with Manzella because Manzella teaches the head support assembly providing freedom of movement, increasing wearability and user comfort [0095; “In this way, the head support assembly 402 provides for additional freedom of movement relative to the shell unit 202 thereby increasing the wearability and user comfort of the helmet or head gear assembly 200.”]
Regarding Claim 3, Thomas teaches device according to claim 1. Thomas is silent on wherein said device is made of sterilisable material.
Manzella teaches wherein said device is made of sterilisable material [0106; The surgical hood 502 may be manufactured from any suitable surgical fabric to help repel water, debris and other containments such as blood born pathogens, and viruses.”]
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 Thomas which discloses the requirement to provide a sterile environment with a pathogen laden area [Col 2, lines 8-10; “It is at times desirable to provide a sterile environment within an otherwise relatively pathogen laden area.”] with Manzella because Manzella teaches the surgical fabric further possessing viral penetration resistance characteristics [0106; “The surgical fabric can be a multilayer fabric which meets or substantially meets the ASTM F1671-97B standard for viral penetration resistance.”]
Claim(s) 5, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (U.S. 5083558) in view of Kerns (WO 2014025702).
Regarding Claim 5, Thomas teaches device according to claim 4, Thomas is silent on wherein said at least one front closable portion (1) is tied to the top part of said device by means of hinges that allow its rotation to switch from closed to open configuration and vice versa.
Kerns teaches wherein said at least one front closable portion (1) is tied to the top part of said device by means of hinges that allow its rotation to switch from closed to open configuration and vice versa [0043; “In certain embodiments, the drape 120 is attached to the frame 118 via one or more mechanical features, including but not limited to a clip, hinge, perforation, or the like.”] In this embodiment the at least one front closable portion is interpreted to be the surgical drape.
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 Thomas which discloses a movable door panel for inserting and removing the patient [Col 6, lines 62-65; “a movable door panel can be slidable over an opening in the endwall of the upper enclosure, for opening and closing an access route whereby the cage box is moved into and out of the compartment.”] with Kerns because Kerns teaches the requirement for access to the patient to allow for use of surgical tools, devices or other surgical resources [0089; “In some embodiments, the hole 108 can be positioned in the center of the drape to allow for access of surgical tools or accessory devices, such as a microscope, a fan, or other surgical tools as described herein.”]
Regarding Claim 9, Thomas teaches Device according to claim 1. Thomas is silent on wherein said at least one pumping system for forming a laminar airflow is positioned on the top sides of said device.
Kerns teaches wherein said at least one pumping system for forming a laminar airflow is positioned on the top sides of said device [Fig. 1D, element 112] and [0006; “In some embodiments, wherein the fan is configured to be located on a side portion of the frame. In some embodiments, wherein the fan is configured to be located on a top portion of the frame.”]
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 Thomas which introduces a fan located on the side portion of the device and feeds air into an upper part of the device [Col 4, lines 55-58; “The air is forced by a fan 92 through a HEP A filter block 96 disposed in the cabinet 26, and is led by a duct 40 along an endwall 36 to an upper part of the enclosure 24.”] with Kerns because Kerns teaches the use of the fan to generate a controlled airflow in the surgical area under the drape [0027; “The ophthalmic surgical drape system can comprise a fan configured to generate a controlled airflow through the area underneath the drape to substantially prevent contaminants from entering the area underneath the drape.”]
Claim(s) 10, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (U.S. 5083558) in view of Netherlands (GB 1308583).
Regarding claims 10 and 11, Thomas teaches device according to claim 1. Thomas is silent on wherein said at least one pumping system for forming a laminar airflow (3) is activated by means of a special switch or automatically when said at least one front closable portion (1) is in closed position and at least one pumping system for forming a laminar airflow (3) is stopped by means of a special switch or automatically when said at least one front closable portion (1) is in open position.
Netherlands teaches wherein said at least one pumping system for forming a laminar airflow (3) is activated by means of a special switch or automatically when said at least one front closable portion (1) is in closed position [Abstract; “the equipment supplying a laminar flow of air through the space” and “The entrance to the space 16 is provided with a folding curtain which upon closing switches off fan 7 and starts fan 4 which provides a smaller flow of air.”]
at least one pumping system for forming a laminar airflow (3) is stopped by means of a special switch or automatically when said at least one front closable portion (1) is in open position [Abstract; “The reverse operation is carried out when the curtain is open. A fan of variable output may replace the two separate fans 4, 7.”]
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 Thomas which discusses sealing the protected space when not in use [Col 4, lines 48-50; “If desired, a closure panel (not shown) can be provided on one or both sides in order to seal the protected space when one or both of the openings is not in use.”] with Netherlands because Netherlands teaches that when the curtain or closable portion is closed, lessened laminar airflow is necessary to keep the space sterile [Pg. 3, lines 18-20; “This switching is effected because when the curtain is in the closed position, a smaller flow of air is needed to keep the space germfree and also because the flow of air through the narrow slit which remains open between front edge and curtain 19 must not become too great.”]
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (U.S. 5083558) in view of Noori (U.S. 20120261593).
Regarding Claim 12, Thomas teaches Device according to claim 1. Thomas is silent on wherein environment therein is sterile already a few tens of seconds after its activation.
Noori teaches environment therein is sterile already a few tens of seconds after its activation [0018; “In an exemplary embodiment, activation of the UV light source results in 5 second pulses of light being delivered for a duration of 60 seconds, although the manner and duration of UV light exposure can be varied while staying within the scope of the invention. Additionally, the UV light source 130 can be manually controlled using control switch 140, whereby pressing the control switch provides a UV light pulsing sequence ( e.g. 5 second pulses of UVC light for a duration of 60 seconds).”]
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 Thomas which discusses maintaining a sterile environment for preventing contamination [Col 3, lines 8-11; “A positive static pressure is maintained between the enclosure and the outside. This feature is important for preventing operative site contamination 10 from areas outside the enclosure.”] with Noori because Noori teaches the frequent spread of germs and infectious organisms in a medical environment [0003; “Nosocomial infections are frequently caused by medical staff that inadvertently spread disease from one patient to another. Poor hand washing, re-use of medical devices, or failure to sterilize the environment, all may increase the chance of distributing the microbial organisms.”]
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (U.S. 5083558) in view of Eriksson (U.S. 20150119857).
Regarding Claim 15, Thomas teaches method with the device according to claim 1. Thomas further teaches said method comprising operating said device [Col 8, lines 28-30; “The invention also encompasses a method for conducting surgical procedures on a subject.”]
and obtaining said sterile conditions [Col 3, lines 42-45].
Thomas is silent on for maintaining face or head wounds under sterile conditions in emergency situations
Eriksson teaches for maintaining face or head wounds under sterile conditions in emergency situations, [0009; “In at least some embodiments, a method of treating a patient having a facial wound may involve debriding the facial wound, fitting a wound treatment device as described herein over a head of the patient, applying at least one therapeutic agent to the wound via the device at a concentration of up to or greater than about 1000 times a concentration suitable for intravenous delivery, and applying negative pressure wound therapy to the treatment space of the device for a sufficient duration to effect healing of the wound.”] and [0086; “Aspects of the present disclosure may be illustrated by the following prophetic example addressing injuries commonly resulting from military combat.”]
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 Thomas which discusses the use of the device in battlefield situations [Col 3, lines 11-16; “Particularly together with means defining an air curtain at the opening, the aspect of excluding outside particles provides the ability to conduct aseptic surgical technique in remote areas such as battlefields and on the site of mass casualty 15 events.”] with Eriksson because Eriksson discusses scenarios of treating wound and burns to the head, face and neck in emergency situations where a negative pressure environment is to be maintained [0087; “A patient was presented with partial and full thickness burns to the head, face, and neck. negative pressure device described herein having an oversized transparent chamber with internally embossed surface structures was applied over the patient's head and neck and sealed proximate the collar bone, above the tracheostomy and gastrostomy tubes.”]
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Fischer (U.S. 5316541)-Discloses sterile enclosure for surgical procedures allowing the surgeon access to the surgical field external to the enclosure.
-Californiaa (U.S. 20080097143)-Includes an incubator/cradle enclosure with similar airflow components to that of the instant application.
-Gnanashanmugam (WO 2014145032)-Provides a method of performing a surgical procedure on a portion of a patient’s body within a sterile and enclosed environment.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791