FINAL 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 Arguments
Applicant's arguments filed September 14th, 2026 have been fully considered but they are not persuasive.
Applicant argues that:
With respect to the "means for supplying a disinfectant substance," Applicant respectfully directs the Examiner's attention to paragraphs [0013], [0036], [0037], [0040] and [0041], in conjunction with fig. 3 of the published application, US 2024/399007 A1.
Paragraph [0036] expressly identifies component (5) as the means for supplying a disinfectant substance, locates means (5) within support base (4) and specifies that means (5) is in communication with the interior of disinfection chambers (2) and (3).
Paragraph [0037] further specifies that means (5) is configured to introduce a controlled quantity or volume of disinfectant into one or each disinfection chamber and, preferably, to supply the disinfectant by nebulization. Such a structural and functional relationship is also reflected in dependent claims 6 and 7, which respectively recite controlled introduction of the disinfectant and nebulization within the chamber.
The disclosure is further developed in paragraphs [0040] and [0041]. In particular, paragraph [0040] explains that operation of the device may involve first supplying a sanitizer and then a cleaning solution and expressly states that the means for supplying will typically involve nebulization. Paragraph [0041] then identifies exemplary disinfectant solutions suitable for disinfection by nebulization.
Applicant respectfully submits that the adequacy of the corresponding structure is assessed from the perspective of a skilled person, considering the specification of the present application as a whole. In the present case, the afore-cited passages, in conjunction with fig. 3, sufficiently identify means (5), its arrangement and its manner of operation. A skilled person would therefore understand the corresponding structure for performing the claimed supplying function, including the conventional mechanical elements implicit in the disclosed controlled supply and nebulization of the disinfectant.
Accordingly, the specification adequately discloses corresponding structure for the "means for supplying a disinfectant substance" and clearly associates means (5) with the function recited in independent claim 1.
Examiner would respectfully respond that:
Paragraphs [0013], [0036], [0037], [0040] and [0041], as well as Figure 3 of Applicant’s published application merely provide a disclosure of where the means for supplying the disinfectant substance is located within the device, and the product (i.e., a nebulized substance), but does not recite the structure involved that produces the disinfectant substance. Applicant’s specification does not provide the corresponding structure to perform the claimed function of supplying a disinfectant substance. Simply stated, a recitation in the specification that the disinfectant is supplied, preferably by nebulization, is not sufficient structure for one of ordinary skill to ascertain the meets and bounds of the claimed limitation. For example, a nebulized substance could be produced with an ultrasonic nebulizer, an atomizing nozzle, or any other component that produces a nebulized substance; but none of this type of structure is provided in Applicant’s specification. As such, claim 1 is rejected under 35 U.S.C. 112(b) because it is unclear what limitations are recited in the claim. Therefore, this response is not persuasive, and the rejection remains.
In order to overcome this rejection, it is suggested to amend the limitation to “a disinfectant substance supplying device” in claim 1 and the associated dependent claims. Such an amendment will obviate the 35 U.S.C. 112(b) rejection for this limitation.
Applicant also argues that:
With respect to the "means of printing configured to generate a label that can be applied to the helmet and containing information about the disinfection," Applicant respectfully directs the Examiner's attention to paragraphs [0014]-[0015] and [0038], in conjunction with fig. 3 of the published application.
Paragraphs [0014]-[0015] expressly provide for means for printing a label applicable to the helmet and describes the information which may be provided on that label, including confirmation of disinfection, date, time, parameters of the disinfection process and/or substances used.
More specifically, paragraph [0038] expressly identifies component (6) as means configured to generate and print a label applicable on the helmet, specifies that means (6) are arranged at the level of support base (4) and identifies their control by control unit (100). Paragraph [0038] further specifies the information that may be printed on the label relating to the disinfection performed. Consistently, dependent claim 8 expressly recites the information printed onto the label, while dependent claim 10 identifies the control unit for the supplying and printing means.
Applicant respectfully submits that the adequacy of the corresponding structure is assessed from the perspective of a skilled person, considering the specification of the present application as a whole. In the present case, the afore-cited passages, in conjunction with fig. 3, sufficiently identify means (6), its arrangement and its manner of operation. A skilled person would therefore understand the corresponding structure for performing the claimed printing function, including the conventional mechanical elements implicit in the disclosed generation and printing of a label applicable to the helmet and containing information relating to the performed disinfection.
Accordingly, we consider that the specification adequately discloses corresponding structure for the "means of printing configured to generate a label that can be applied to the helmet and containing information about the disinfection" and clearly associates means (6) with the function recited in independent claim 1.
The Examiner would respectfully respond that:
Similar to the “means for supplying a disinfectant substance” as discussed above, the Applicant’s instant specification does not provide a disclosure of the corresponding structure to perform the act of “printing to generate a label”. Simply pointing to the paragraphs in the Applicant’s instant specification that say “means configured to generate and print a label” or “means for printing a label” followed by what can be printed on the label, and where the “means for printing” is located within the device is not enough disclosure to invoke 35 U.S.C. 112(f); and certainly does not provide the corresponding structure to perform the functional “printing” of the label. As such, this limitation is unclear to one of ordinary skill as to what is or is not claimed by this “means of printing”. Therefore, the limitation is rejected under 35 U.S.C. 112(b).
It is suggested to amend claim 1 (and the associated dependent claims) to, “a printer configured to generate a label…” in order to overcome this rejection. Appropriate action is required.
Applicant continues to argue that:
Turning more specifically to disinfection unit (6), Van Den Houdt does not disclose that its chamber is configured to accommodate a single surgical helmet, let alone that such chamber has a prevalent extension along a sagittal plane of the helmet. In this respect, Applicant notes that, although the examples of Van Den Houdt primarily relate to dental instruments, paragraph [0069] expressly contemplates use of the decontamination device for instruments or implants pertaining to several other medical fields, as well as for articles used in a medical environment. The latter may include, for example, cellphones, beepers, stethoscopes and pens. Notwithstanding the variety of instruments and articles expressly identified as suitable for treatment by the decontamination device, Van Den Houdt makes no reference to surgical helmets.
Moreover, Van Den Houdt consistently discloses an arrangement intended to receive and process instrument (12), cassette (14) and/or a plurality of instruments (12). Paragraph [0019], for example, specifies that a cassette may hold a plurality of instruments, a specific instrument or type of instrument, or one or more instruments of different types. The detailed description correspondingly refers to cassette (14) and/or instruments (12) being processed through the washing and disinfection units. See, e.g., paragraphs [0050]-[0051]; figs. 1 and 3.
By contrast, independent claim 1 requires an internal compartment configured to accommodate a single surgical helmet, with the chamber geometry itself further defined in relation to the helmet by its prevalent extension along the sagittal plane. Paragraph [0011] of the published application explains that each disinfection chamber extends predominantly in the antero-posterior and vertical directions and has a reduced thickness in the transverse direction. See also figs. 1A-2. As a result, the claimed chamber is dimensioned and configured in relation to the geometry and orientation of a single surgical helmet, for which Van Den Houdt provides no corresponding disclosure.
The Examiner would respectfully respond that:
The Applicant is reminded that the claims are directed to a disinfection device, wherein The Manual of Patent Examining Procedures (MPEP), specifically states that, "expressions relating the apparatus to content thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." (MPEP 2115 [R-2]). Still further, the MPEP denotes that, “while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function” (MPEP 2114).
The Applicant has claimed a “disinfection device for one or more surgical helmets”. Because the device of Van Den Houdt is fully capable of disinfecting one or more surgical helmets, then said device meets the limitations of the claims. More specifically, the device of Van Den Houdt clearly discloses at least one box-shaped disinfection chamber (4/6) presenting a plurality of side walls defining an internal compartment in Figures 1, 3 & 4 and paragraphs 46-56). Furthermore, said disinfection chamber is fully capable of, and configured to accommodate within it any arbitrary (non-claimed) single helmet to be disinfected; wherein said chamber (4/6) has a prevalent extension along a sagittal plane of the arbitrary unclaimed helmet (Figures 1, 3 & 4; paragraphs 46-56).
Thus, this response is not persuasive, and the limitations are met by Van Den Houdt as currently set forth.
Applicant finally argues that:
Applicant also submits that Van Den Houdt fails to disclose the portability feature recited in independent claim 1. In the present application, portability is expressly associated with the configuration of device 1. In particular, paragraph [0048] states that "[a]ccording to the described configuration, the device 1 is easily transportable and in particular portable." Hence, in the context of the present application, the claimed portability reflects a configuration by virtue of which the device is readily capable of being transported.
No analogous teaching is provided by Van Den Houdt. To the contrary, in the embodiment of fig. 1, reception unit (2), and in particular a loading door (ref. 3), is physically separated from delivery unit (10), and in particular an unloading door (ref. 38). Van Den Houdt expressly provides that loading door (3) may be located in a first room and unloading door (38) in a different second room, in which case decontamination device 1 extends through the wall separating the two rooms. See paragraph [0054]; fig. 1.
Applicant also notes that, in the alternative embodiment of fig. 4, decontamination device (1) may be embodied as a desktop or countertop device. Van Den Houdt further states that its size may correspond to that of general kitchen appliances, such as an oven or microwave oven, with exemplary dimensions of approximately 60 cm X 40 cm X 50 cm, and that the device may be integrated into a cupboard of a dental practice. See [0063]; fig. 4.
Nevertheless, Van Den Houdt provides no teaching that such embodiment is portable or readily transportable. We consider that the mere disclosure of a desktop or countertop arrangement, particularly one expressly contemplated for integration into a cupboard, does not amount to an express disclosure of the claimed portable device.
More importantly, even assuming that the embodiment of fig. 4 were regarded as portable, Van Den Houdt would still fail to disclose the claimed combination. In particular, there is no disclosure that the chamber of the fig. 4 embodiment is configured to accommodate a single surgical helmet or that it has a prevalent extension along a sagittal plane of such helmet. Instead, the fig. 4 embodiment retains the decontamination arrangement disclosed in the preceding embodiments, with washing unit (4), disinfection unit (6) and wrapping unit (8) sharing the same space.
Accordingly, Van Den Houdt fails to disclose the specific combination of a portable automatic disinfection device having a box-shaped disinfection chamber whose internal compartment is configured to accommodate a single surgical helmet and whose prevalent extension is arranged along a sagittal plane of the helmet. Such distinguishing features of independent claim 1 cooperate in providing a compact disinfection device specifically adapted to the geometry of a single surgical helmet. In particular, the single-helmet compartment and its prevalent extension along the sagittal plane allow the chamber to be configured according to the characteristic dimensions and orientation of the helmet, thereby providing an effective, space- efficient and readily transportable device specifically configured for surgical helmet disinfection.
The Examiner would respectfully respond that:
It appears as though the Applicant is affording too much weight to the limitation of “portable”, a limitation provided in the preamble no less. Applicant’s reference that the device of Van Den Houdt is configured such that the, “loading door (3) may be located in a first room and unloading door (38) in a different second room, in which case decontamination device 1 extends through the wall separating the two rooms” is a disclosure that such a device necessarily must be portable in order to assemble different portions of the device in different rooms. Stated differently, the device of Van Den Houdt is fully capable of being disassembled, transported to a different location, and reassembled in said different location. Such a construction is a clear disclosure of portability.
Furthermore, the disclosure by Van Den Houdt that the device “may be embodied as a desktop or countertop device, wherein its size may correspond to that of general kitchen appliances, such as an oven or microwave oven, with exemplary dimensions of approximately 60 cm X 40 cm X 50 cm” is further support that the device is portable; as anyone of ordinary skill knows that an oven or microwave oven is necessarily “portable”, especially with the dimension of 60 cm X 40 cm X 50 cm.
Still further, to the reference by the Applicant that the embodiment of Figure 4 (oven/microwave oven with above claimed dimensions) in Van Den Houdt is not configured to accommodate a single surgical helmet in which said device has a prevalent extension along a sagittal plane of such a helmet; the Examiner would reiterate (as noted above) that the helmet is not positively recited. As such, dependent on various factors (including the size of the helmet), the embodiment of Figure 4 of Van Den Houdt is fully capable of accommodating a single arbitrary (non-claimed) surgical helmet in which said device has a prevalent extension along a sagittal plane of such an arbitrary (non-claimed) helmet. Thus, Van Den Houdt fully meets these limitations as claimed, and this response is not persuasive.
Examiner’s final response:
Because the arguments noted above are not found persuasive, then claims 1-11 remain rejected as noted below. Therefore, this Office Action is deemed FINAL.
Claim Interpretation
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.
As such, the claim limitations “means for supplying a disinfectant substance” and “means of printing” has been interpreted under 35 U.S.C. 112(f), because said limitations use the non-structural term “means” coupled with functional language “for supplying a disinfectant substance” and “of printing” without reciting sufficient structure to achieve the function. Furthermore, the non-structural term is not preceded by a structural modifier.
Since these claim limitations invoke 35 U.S.C. 112(f), claim 1 is interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
However, a review of the specification does not appear to provide the corresponding structure described in the specification for the 35 U.S.C. 112(f), sixth paragraph limitation. As such, a 35 U.S.C. 112(b) rejection for the limitations of “means for supplying a disinfectant substance” and “means of printing” is set forth below.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not wish to have the claim limitation treated under 35 U.S.C. 112(f), applicant may amend the claim so that it will clearly not invoke 35 U.S.C. 112(f), or present a sufficient showing that the claim recites sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f).
For more information, see Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. § 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 1-10 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 limitations “means for supplying a disinfectant substance” and “means of printing” invoke 35 U.S.C. 112(f). 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. 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 3 recites the limitation "said or each of said disinfection chambers" in line 1 to line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend to, “said one or each of said disinfection chambers”. Appropriate action is required.
Claims 2 and 4-10 are rejected merely due to their dependency on claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 5-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Den Houdt et al. (U.S. Publication No. 2021/0236236).
Van Den Houdt discloses a portable automatic disinfection device for one or more surgical helmets (Abstract; Figures 1-4), which the disinfection device comprises:
At least one box-shaped disinfection chamber (4/6) presenting a plurality of side walls defining an internal compartment configured to accommodate within it a single helmet to be disinfected and having a prevalent extension along a sagittal plane of the helmet (Figures 1, 3 & 4; paragraphs 46-56);
Means for supplying a disinfectant substance, in communication with the interior of said disinfection chamber (paragraph 51); and
Means of printing (57) configured to generate a label that can be applied to the helmet and containing information about the disinfection (paragraph 57).
Regarding claim 2, Van Den Houdt also discloses a pair of disinfection chambers (4 & 6) arranged juxtaposed one to the other (Figure 1), each box-shaped, having a prevalent extension along a sagittal plane and configured to house a respective helmet to be disinfected (Figure 1; paragraphs 50 & 51), said means for supplying a disinfectant substance being in independent communication with the interior of each of said disinfection chambers (paragraphs 50 & 51).
Concerning claim 3, the reference discloses that the chambers (4 & 6) are openable via doors (40, 44 and 46) for the introduction of said surgical helmet inside thereof (paragraph 53).
With respect to claims 5 & 11, Van Den Houdt continues to disclose a means (14 and/or hook or clamp) for retaining a helmet, arranged within said one or each of said disinfection chambers (4/6), wherein said means for retaining the helmet is of the latching type (i.e., hook or clamp) as set forth in paragraphs 46 and 47.
Regarding claim 6, Van Den Houdt also discloses that the means for supplying a disinfectant substance are configured for introducing a controlled quantity or volume of disinfectant into one or each disinfection chamber (paragraphs 50 & 51).
Concerning claim 7, Van Den Houdt further discloses that said means for supplying are configured for a nebulization (i.e., mist) of a disinfectant substance within said one or each of said disinfection chambers (paragraphs 15, 16 and 50).
With respect to claim 8, the reference discloses that the printing means is configured to print onto the label the date, time and parameters of the disinfection process (paragraph 57).
Regarding claim 9, Van Den Houdt discloses that the device comprises a support base (50) for an operator carrying a user interface (paragraph 55).
Concerning claim 10, Van Den Houdt further discloses a control unit (18) of said means for supplying (paragraphs 50 & 51) and said means for printing (paragraph 57), which control unit (18) is programmed to perform one or more disinfection processes (paragraphs 50 & 51).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Van Den Houdt et al. (U.S. Publication No. 2021/0236236) in view of Hall et al. (U.S. Publication No. 2022/0305152).
Van Den Houdt is relied upon as set forth above. Van Den Houdt does not appear to disclose that the chamber has a transparent viewing window. Hall discloses a portable automatic disinfection device for surgical helmets that includes a box-shaped disinfection chamber (paragraph 41), and a means (114) for supplying a disinfectant substance to said helmet as set forth in paragraph 45 (Abstract; Figures 1 & 2). The reference continues to disclose that the chamber comprises a transparent viewing window (110) in order to allow a user to observe the disinfection process (paragraph 43). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the chambers of Van Den Houdt with a transparent viewing window in order to allow a user to observe the disinfection process as exemplified by Hall.
Therefore, claim 4 is not patentable over Van Den Houdt in view of Hall.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN C JOYNER whose telephone number is (571)272-2709. The examiner can normally be reached Monday-Friday 8:00AM-4:30PM.
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/KEVIN JOYNER/Primary Examiner, Art Unit 1799
