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 .
Specification
The spacing of the lines of the specification is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
The mention of Application No. 63/360,526 as cross-referenced, appears to be trying to claim priority to the Provisional Application. However, for priority to be claimed this should appear on the ADS.
Priority
This application makes reference to or appears to claim subject matter disclosed in Application No. 63/360,526, filed on 12/20/2021. If applicant desires to claim the benefit of a prior-filed application under 35 U.S.C. 119(e), 120, 121, 365(c) or 386(c), the instant application must contain, or be amended to contain, a specific reference to the prior-filed application in compliance with 37 CFR 1.78. If the application was filed before September 16, 2012, the specific reference must be included in the first sentence(s) of the specification following the title or in an application data sheet (ADS) in compliance with pre-AIA 37 CFR 1.76; if the application was filed on or after September 16, 2012, the specific reference must be included in an ADS in compliance with 37 CFR 1.76. For benefit claims under 35 U.S.C. 120, 121, 365(c), or 386(c), the reference must include the relationship (i.e., continuation, divisional, or continuation-in-part) of the applications.
If the instant application is a utility or plant application filed under 35 U.S.C. 111(a), the specific reference must be submitted during the pendency of the application and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior application. If the application is a national stage application under 35 U.S.C. 371, the specific reference must be submitted during the pendency of the application and within the later of four months from the date on which the national stage commenced under 35 U.S.C. 371(b) or (f), four months from the date of the initial submission under 35 U.S.C. 371 to enter the national stage, or sixteen months from the filing date of the prior application. See 37 CFR 1.78(a)(4) for benefit claims under 35 U.S.C. 119(e) and 37 CFR 1.78(d)(3) for benefit claims under 35 U.S.C. 120, 121, 365(c), or 386(c). This time period is not extendable and a failure to submit the reference required by 35 U.S.C. 119(e) and/or 120, where applicable, within this time period is considered a waiver of any benefit of such prior application(s) under 35 U.S.C. 119(e), 120, 121, 365(c), and 386(c). A benefit claim filed after the required time period may be accepted if it is accompanied by a grantable petition to accept an unintentionally delayed benefit claim under 35 U.S.C. 119(e) (see 37 CFR 1.78(c)) or under 35 U.S.C. 120, 121, 365(c), or 386(c) (see 37 CFR 1.78(e)). The petition must be accompanied by (1) the reference required by 35 U.S.C. 120 or 119(e) and by 37 CFR 1.78 to the prior application (unless previously submitted), (2) the applicable petition fee under 37 CFR 1.17(m)(1) or (2), and (3) a statement that the entire delay between the date the benefit claim was due under 37 CFR 1.78 and the date the claim was filed was unintentional. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
If the reference to the prior application was previously submitted within the time period set forth in 37 CFR 1.78 but was not included in the location in the application required by the rule (e.g., if the reference was submitted in an oath or declaration or the application transmittal letter), and the information concerning the benefit claim was recognized by the Office as shown by its inclusion on the first filing receipt, the petition under 37 CFR 1.78 and the petition fee under 37 CFR 1.17(m)(1) or (2) are not required. Applicant is still required to submit the reference in compliance with 37 CFR 1.78 by filing an ADS in compliance with 37 CFR 1.76 with the reference (or, if the application was filed before September 16, 2012, by filing either an amendment to the first sentence(s) of the specification or an ADS in compliance with pre-AIA 37 CFR 1.76). See MPEP § 211.02.
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 1-9 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.
Regarding claim 1, in line 2 of the claim the claim states “variably flexible plastic material”. This is seen as indefinite as it is unclear what the parameters or “variably flexible” are. Does this mean that the material its self is flexible or are parts of the material are flexible while others are not. For examination purposes, this is seen as a flexible material
In line 2 of the claim, the claim states “of variable possible dimensions” this is seen as indefinite as there are no concrete dimensions claimed for the device therefore it appears to be claiming all infinite amount of the dimensions for which a clear, flexible material can be.
In line 2-5 or the claim, the claim sets forth that the material is limited by the procedure for which it is performing, however, it is unclear what procedure this actually is as the preamble of the claim sets forth percutaneous and other procedures. Meaning that it appears that this could be material for any procedure known. The claim appears to almost be written as an all covering claim and trying to cover all known clear, flexible materials that can be used in all known procedures. This is seen as indefinite.
For examination purposes for the purpose of the examiner interpreting the claim, this is seen as a plastic material enclosure that is clear and flexible.
Regarding claims 2-9, the claims state, “the device of Claim 1”, however, claim 1 states it is a system. It is unclear if the device being claimed in claims 2-9 refer back to the system or the plastic material. It is recommended that consistency be used through the claims and if the system is meant to be claimed then claims 2-9 should state “the system of Claim 1” and any other mention of the device should be made clear as being the “plastic material” or the system.
Regarding claim 2, the claim inherits the deficiencies from claim 1 from which it depends. It is further noted that the claim only really claims one or more gloved areas. It is not clear if these gloved areas are part of the plastic material or separate as set-forth by the claim. It is suggested for clarity and to take the claim out of intended use category that the claim read. “The device of Claim 1, wherein the clear, flexible plastic material further comprises one or more gloved internal projecting areas configured to place the hands and configured to allow for manipulation of instruments within the internally sterile system”.
Regarding claim 3, the claim inherits the deficiencies from claim 1 from which it depends. Furthermore, there are two references to claim 1, this creates antecedent basis issues as it is not clear what parts of claim 1 would be the first mention of elements within the claim language of claim 3. Furthermore, it is unclear if claim 3 is claiming a process of using the device or if the claim is merely claiming further limitations of the actual device in claim 1.
Further, the claim states “variable possible dimensions” which in both instances is seen as indefinite as this could be an infinite possibility of dimensions.
For examination purposes, the claim is seen as the enclosure having a perimeter and an opening that can be sealed all the other language is seen as the use of said enclosure.
Regarding claim 4, the claim in lines 1-2 states “multitude of possible shapes and locations” this is seen as indefinite because its is not clear the boundaries of the claim as it appears that the pocket can be anywhere and anything.
Furthermore, it is unclear the boundaries of the claim as claim 4 depends off of claim 1 which already defines the plastic material, however, in line 3 of the claim the claim sets forth the plastic of the device in claim 1 which makes it unclear if there are multiple devices within the system as claimed. It appears this is merely stating the functionality of the pocket. It is suggested to use “configured to” language.
Therefore, for examination purposes, the claim is seen as a pocket, all other language is seen as the intended use of the pocket and not further limiting.
Regarding claim 5, “the expansion of the device” in line 1 and “the interior of the device” in line 2, seen as lacking antecedent basis as there is no previous mention of “expansion” in claim 1 and there is no mention of “a device” in claim 1 nor “an interior”. This makes it unclear which device the claim is referring to.
The claim also uses the language of “may be” in line 2 of the claim. This is seen as indefinite as it is unclear if the language after “may be” is actively being claimed.
Therefore for examination purposes claim 5 is seen as a support, all other language is seen as the intended use of the support and therefore not further limiting.
Regarding claim 6, inherits the deficiencies from claim 1 from which it depends. It is noted that the language “for use” is seen as the intended use of the device and therefore if there are external loops, they would be able to be used for the function as claimed.
For examination purposes, claim 6 is seen as claiming integral external loops. All other language is seen as the intended use of the loops and not further limiting.
Regarding claim 7, the claim uses the language of “of various possible dimensions in any location on the device” which is seen as indefinite as it is claiming the location and dimension of any possible combination which is seen as infinite. The claim also uses the language of “may be opened and all or some needed materials added or subtracted in sterile fashion and the door closed with sterile internal working area preserved using adhesive edges on the flaps of the opening to reseal the opening”. This language is indefinite as it is unclear if the ”may be” language actively is being claimed.
For examination purposes this is seen as intended use of the flap and therefore the claim is interpreted as a flap with an opening.
Regarding claim 8, the claim states “at any location in the device to allow for internal air expansion of the device as needed from its compressed state when the device is first removed from its container”. The language of “at any location” and “as needed” are seen as indefinite as it does not give a clear boundary of the claim and the location of the element being claimed, and it is unclear what would be seen as “needed” as this is dependent on different factors and can be seen as relative.
Therefore, for examination purposes, the claim is seen as claiming a bacterial filter. All other language is seen as intended use of said filter.
Regarding claim 9, the claim is seen as indefinite as it is unclear what the boundaries of the claim are. The claim sets forth “more flexible” and “at a multitude of possible locations, sizes and shapes as needed”. “More flexible” is seen as indefinite as it is unclear what designates what parts or areas are more flexible than others or if the window is being more flexible than solid. Claiming all possible locations, sizes and shapes make the claims indefinite as this makes infinite possibilities. “Increased clarity” is also seen as indefinite as it is unclear to what the clarity is increasing as there is no comparison.
For examination purposes, this is seen as a window.
Regarding stating all shapes, sizes, dimensions and locations of elements in the claims. It is suggested to just claim the element. For example in claim 9 to just claim a flexible window. This would cover multiple locations, sizes and shapes without the indefinite issue. It appears also that all claims are for elements within the plastic material. It is suggested to amend the claims to state the following:
*These are merely suggestions to amend the claims for clarity and indefiniteness.
1) An internally sterile system [[for]] configured to performing percutaneous and other medical procedures, comprising: a clear, [[variably]] flexible plastic material configured to provide a sterile internal working area.
2) The [[device]] system of Claim 1, further comprising [[with]] one or more gloved internally projecting areas [[for]] configured to accept to allow for access to
3) The [[device]] system of Claim 1, further comprising [[with]] an opening with a protective cover configured to be detachably attached to the system
4) The [[device]] system [[in]] of Claim 1, further comprising [[with]] a pocket configured to house an ultrasound probe
5) The [[device]] system [[in]] of Claim 1, further comprising [[with]] a mobile bracing material configured to adjust the shape of the system
6) The [[device]] system [[in]] of Claim 1, further comprising [[with]] integral external loops
7) The [[device]] system [[in]] of Clam 1, further comprising [[with]] a resealable flap and [[overlying]] opening, the resealable flap and opening having adhesive edges
8) The [[device]] system [[in]] of Claim 1, further comprising [[with]] a bacterial filter configured to allow for internal air expansion of the system system [[device]] is first removed from its container.
9) The [[device]] system [[in]] of Claim 1, further comprising [[with]] a configured to provide an area to view a procedural working area of the system
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.
Claim(s) 1-3 and 5-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reichman et al., US 6461290, herein referred to as “Reichman”.
Regarding claim 1, Reichman teaches: An internally sterile system for performing percutaneous and other procedures (Fig. 1) comprising a clear, variably flexible plastic material of variable possible dimensions as required by the procedure to be performed with sterile internal working area and various instruments and devices as needed for performing a procedure contained within the sterile area of the device (Fig. 1 and column 6, lines 30-56; specifically the housing is made up of transparent flexible plastic).
Figure 1 of Reichman is reproduced below for convenience.
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Regarding claim 2, Reichman teaches: The device of Claim 1 (see above) with one or more gloved internally projecting areas for placing the hands and manipulation of instruments and other devices contained within (Fig. 1-3; glove ports elements are 150a-h).
Regarding claim 3, Reichman teaches: The device of Claim 1 (see above) with an area of attachment of device to skin overlying the area where the procedure is to be performed with an opening of variable possible dimensions and a protective cover of variable possible dimensions over that opening that is peeled away to reveal the opening and a perimeter of an adhesive area of variable possible dimensions under the cover that was peeled away to secure the device in Claim 1 to the skin (Fig. 4 and column 9 lines 1-30 pass through ports 110 for passing through items which are openable ports).
Regarding claim 5, Reichman teaches: The device of Claim 1 (see above) with the expansion of the device as needed supported by mobile bracing material in the interior of the device that may be adjustable in shape and in position along the device as needed to achieve desired visibility and enhance dexterity required for the procedure (Figs 1-3 and 26; Column 8, lines 14-30; the deformable ribs and supports for the collapsable pod).
Regarding claim 6, Reichman teaches: The device of Claim 1 (see above) with integral external loops for use with external bracing or other external support of loops that will be utilized to expand the device as needed (Column 8, lines 14-30; the deformable ribs and supports for the collapsable pod can interact with sleeves which are seen as loops).
Regarding claim 7, Reichman teaches: The device of Claim 1 (see above) with a resealable flap and overlying opening of various possible dimensions in any location on the device that may be opened and all or some needed materials added or subtracted in sterile fashion and the door closed with sterile internal working area preserved using adhesive edges on the flaps of the opening to reseal the opening (Fig. 4 and column 9 lines 1-30 pass through ports 110 for passing through items which are openable ports).
Regarding claim 8, Reichman teaches: The device of Claim 1 (see above) with a bacterial filter at any location in the device to allow for internal air expansion of the device as needed from its compressed state when the device is first removed from its container (claim 9, an air filtration device that aids in inflation of the device and column 2, lines 1-3 filtration of air (so a filter) to not allow for contamination).
Regarding claim 9, Reichman teaches: The device of Claim 1 (see above) with a solid or more flexible window of increased clarity at a multitude of possible locations, sizes and shapes as needed to improve visualization of procedural working areas (column 14, lines 1-15; that there can be windows).
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 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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reichman in view of Gharib, US 20110297163, herein referred to as Gharib.
Regarding claim 4, Reichman discloses: The device in Claim 1 (as seen above) Reichman further describes in Fig. 4 and column 9 lines 1-30 pass through ports 110 for passing through items which are openable ports where different medical devices can be used in and with the pass through ports. Reichman does not explicitly disclose that the system has pockets.
However, Garhib discloses: with a pocket of a multitude of possible shapes and locations that allows an ultrasound probe to be placed into the pocket to enable ultrasound interface between the probe, the plastic of the device in Claim 1 and the skin and thus facilitate ultrasound guidance of procedures (Fig. 2-3; element 18 which is seen as the pocket which an ultrasound probe can be inserted).
Garhib Fig. 2 reproduced below for convenience:
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It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the containment apparatus of Reichman to include the ultrasound pocket as seen in Garhib. The motivation being allowing for sterile environment for different procedures as seen in Garhib, [0006] and [0008].
Conclusion
It is noted to look at the claims of the prior art cited above. These claims illustrate proper claim construction.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOANNE M RODDEN whose telephone number is (303)297-4276. The examiner can normally be reached Monday - Friday 9:00 AM-5:00 PM MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOANNE M RODDEN/ Supervisory Patent Examiner, Art Unit 3794