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 .
Response to Amendment
This office action is in response to the amendment filed 04/26/24. Claim(s) 1-14 have been amended, no new claims have been added, and no claims have been cancelled. Thus, claims 1-14 are presently pending in this application.
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 "a gown" in claim 12; "a kit" in claim 13; and "a sterile package" in claim 14 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.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“coupling means”: through hole “31” (page 4, lines 14-15 of the specification)
“forced air circulation means”: ventilation means (see below) “103” (page. 8, lines 15-20)
“ventilation means”: axial or radial blowers “131 or 132” (pg. 8, lines 20-21 of specification).
Claim Objections
Claims 10 and 12 are objected to because of the following informalities:
In claim 10, line 1 "a protective cap" should be changed to --the protective cap--.
In claim 12, line 1 "a protective cap" should be changed to --the protective cap--. 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 2, 9, 12, and 14 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.
In claim 2, the limitation “shaped like a bib” is unclear. The term “like” renders the claim indefinite as it cannot be determined if the shape is a bib or not a bib.
In claim 9, line 2 the limitation “disposable type” is unclear. The term “type” renders the claim indefinite as one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 12 recites the limitation "The assembly" in line 1. There is insufficient antecedent basis for this limitation in the claim.
In claim 14, lines 1-2 the limitation “a sterile protective cap” is unclear if this is referring to the protective cap in claim 1 or a new cap.
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) 1-2, 4-5, 7, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over VanDerWoude (2009/0151054) in view of Jefferis (10,420,386).
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Annotated fig 5 of VanDerWoude.
With respect to claim 1, VanDerWoude discloses a protective cap (24, fig 3) configured to be worn over a helmet (22, fig 5) by an operator (see [0026]), in particular in an operating room (see [0001]), which protective cap comprises a front vision lens (60, fig 5), configured to position at least at the operator's eyes (see [0028]); an enveloping main body (50, fig 5), fixed to said vision lens at a peripheral region thereof (see [0028-29]) and configured to completely cover the operator's head, neck and upper chest (see fig 11 and [0026]), which enveloping main body comprises a front portion (see annotated fig 5 of VanDerWoude) and a rear portion (see annotated fig 5 of VanDerWoude) connected and made integral by two opposite side portions (see annotated fig 5 of VanDerWoude; note only one is labeled but the cap in 3D and thus has two sides), wherein said main body further comprises a filtering portion (52, fig 5) configured to screen viral and bacterial agents (see [0027]), which filtering portion is arranged at an upper and middle-rear part of the main body that is placed (see location of 52 in fig 5; where 52 is at the crown of the operator’s head), on the operator's skull, wherein said filtering portion is joined to a surrounding part of said main body (see [0027]) but lacks the filtering portion joined by ultrasound welding.
However, Jefferis teaches a protective cap (12, fig 1) comprising an enveloping main body (14, fig 1) comprising a filtering portion (16, fig 1), wherein said filtering portion is joined to a surrounding part of said main body (see connection by ultrasound welding (see col. 8, lines 23-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the attachment of the main body and filtering portion of VanDerWoude to be welded as taught by Jefferis so as to provide a well-known connection between two pieces of material.
With respect to claim 2, the modified VanDerWoude shows said front portion has a lower appendix shaped like a bib (see annotated fig 5 of VanDerWoude), which, extends on the operator's chest (see fig 11 of VanDerWoude).
With respect to claim 4, the modified VanDerWoude shows said filtering portion comprises a rear portion having a downwardly tapered shape (see annotated fig 5 of VanDerWoude where 52 extends down the shroud 50).
With respect to claim 5, the modified VanDerWoude shows said enveloping main body is made of polypropylene tri-laminate with the exception of said filtering portion (see “multilaminate nonwoven… polypropylene” [0027] of VanDerWoude).
With respect to claim 7, the modified VanDerWoude shows said vision lens has connection means (mounting elements; 68, fig 5 of VanDerWoude), to a surgical helmet (see [0033] of VanDerWoude).
With respect to claim 10, the modified VanDerWoude shows an assembly (24, fig 5 of VanDerWoude) comprising the protective cap according to claim 1 (see claim 1 above) and a surgical helmet (22, fig 5 of VanDerWoude) connectable to said vision lens (see [0033] of VanDerWoude), wherein said protective cap is adapted to be worn over said surgical helmet (see [0026] of VanDerWoude).
With respect to claim 11, the modified VanDerWoude shows said helmet comprises forced air circulation (36, fig 2A of VanDerWoude) means having ventilation means (38, fig 2 of VanDerWoude) configured to suck in external air and said filtering portion of said cap is configured to be arranged over a suction mouth of said ventilation means (see [0027] of VanDerWoude).
With respect to claim 12, the modified VanDerWoude shows an assembly comprising the protective cap according to claim 1 (see claim 1 above) and a gown that can be worn over a lower part of said enveloping main body (see [0040] not shown but a gown accommodates the hood).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over VanDerWoude and Jefferis as applied to claim 1 above, and further in view of Wilson (1,928,238).
With respect to claim 3, the modified VanDerWoude shows all the elements as claimed above but is silent regarding the cap comprising a first and a second lateral tie rod, each one fixed, at a respective terminal end, on said enveloping main body, said first and second tie rod being arranged on opposite sides with respect to a longitudinal axis of the cap and configured to be wrapped, at the end of wearing the cap, around the chest and connected to each other.
However, Wilson teaches a cap (10, fig 1) comprising a first and a second lateral tie rod (18, fig 1; two straps), each one fixed, at a respective terminal end (see connection on the rear of the device in fig 1), on a enveloping main body (15, fig 1), said first and second tie rod being arranged on opposite sides with respect to a longitudinal axis of the cap (see straps on left and right of the center of the cap) and configured to be wrapped, at the end of wearing the cap, around the chest and connected to each other (see straps with fitting 14 that can be attached fig 1; pg. 1, lines 87-89).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cap of the modified VanDerWoude to include tie rods as taught by Wilson so as to draw the device tightly against the body of the wearer for a secure fit (see pg. 1, lines 87-89 of Wilson).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over VanDerWoude and Jefferis as applied to claim 1 above, and further in view of Miu (CN103623516).
With respect to claim 6, the modified VanDerWoude shows the filtering portion is made of a monolayer or multilayer filtering material (see [0027] of VanDerWoude) suitable to guarantee a filtration of viruses and bacteria (see [0027] of VanDerWoude), but is silent regarding the filtration of viruses and bacteria higher than 99%.
However, Miu teaches a protective cap (30/31; fig 1) comprising a filtering portion (19, fig 1) made of filtering material (HEPA) suitable to guarantee a filtration of viruses and bacteria higher than 99% (see [0030] of translation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the filter portion of the modified VanDerWoude to include a HEPA filter as taught by Miu so as to filter contaminated air to provide purified air by blocking fine particulate matter (see [0030] of Miu).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over VanDerWoude and Jefferis as applied to claim 1 above, and further in view of Klotz (6,990,691).
With respect to claim 9, the modified VanDerWoude shows all the elements as claimed above but is silent regarding the protective cap being disposable.
However, Klotz teaches a protective cap (shroud; 140, fig 17) of the disposable type (see col. 4, lines 51-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the protective cap of the modified VanDerWoude to be disposable as taught by Klotz so as to provide a one time use cap that is sterile at use and disposed of after to avoid contamination.
Claim(s) 8 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over VanDerWoude and Jefferis as applied to claim 10 and 1 above, and further in view of Wheeler (4,845,779).
With respect to claim 8, the modified VanDerWoude shows all the elements as claimed above but is silent regarding the protective cap is supplied sterile in a package.
However, Wheeler teaches a protective gown (32, fig 13a) comprising a sterile package (gown, hood, gloves; see fig 14 and col. 5, lines 18-38).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assembly of the modified VanDerWoude to be provided as a kit as taught by Wheeler so as to provide multiple parts (gown, hood, gloves) in one convenient package for the operator.
With respect to claim 13, the modified VanDerWoude shows all the elements as claimed above but is silent regarding the assembly is supplied as a kit.
However, Wheeler teaches a protective gown (32, fig 13a) supplied as a kit (gown, hood, gloves; see figs 13a-13f and col. 5, lines 18-38).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assembly of the modified VanDerWoude to be provided as a kit as taught by Wheeler so as to provide multiple parts (gown, hood, gloves) in one convenient package for the operator.
With respect to claim 14, the modified VanDerWoude shows the protective cap of claim 1 (see claim 1 above) but is silent regarding a sterile package, which comprises a wrapping, wherein said protective cap is housed in said wrapping in folded form.
However, Wheeler teaches a protective gown (32, fig 13a) comprising a sterile package (gown, hood, gloves; see fig 14 and col. 5, lines 18-19) which comprises a wrapping (synthetic package; 60, fig 14) wherein said protective gown is housed in said wrapping in folded form (see fig 14 and col. 5, lines 18-38).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cap of the modified VanDerWoude to be provided as a sterile package as taught by Wheeler so as to provide multiple parts (gown, hood, gloves) in one convenient package for the operator.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Resnick (2010/0313338), Duncan (2009/0144884), Paris (2001/0037519), Stackhouse (4901716), Jurrius (5133344), Yazdi (2016/0165973), Jascomb (2020/0178622), and Christensen (2021/0093024) are cited to show additional protective wearables.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KELSEY E BALLER/ Examiner, Art Unit 3785
/TU A VO/ Primary Examiner, Art Unit 3785
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