DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The specification (including the abstract and claims), and any amendments for applications, except as provided for in 37 CFR 1.821 through 1.825, must have text written plainly and legibly and presented in a form having sufficient clarity and contrast between the paper and the writing thereon to permit the direct reproduction of readily legible copies in any number by use of photographic, electrostatic, photo-offset, and microfilming processes and electronic capture by use of digital imaging and optical character recognition (OCR). See 37 CFR 1.52(a) and (b).
The application papers filed 18 January 2024 are objected to because the amendments to the claims, presumably due to the use of a color other than black to mark changes to the claims, is difficult to read and/or electronically reproduce by use of OCR.
Since Applicant's amendments can be discerned by the examiner, said amendments have been entered. However, the examiner respectfully requests use of black colored font for text on a white background in any future claim listing(s) submitted by Applicant, consistent with the recommendations by the Office (see MPEP 608.01(I), "In order to enhance readability of electronic submissions, the USPTO strongly recommends use of a black colored font for text on a white background"). With entry of said amendments, claim(s) 4-8, 13, 16-18 and 20 is/are currently amended. Claim(s) 1-20 is/are pending.
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, a protective sheath having a first portion comprising a peelable first side disposed on the first major side of the piece of porous sample collection media and a peelable second side disposed on the first major side of the piece of porous sample collection media (claim 5) (e.g., two peelable "sides" disposed on the same major side of the sample media) 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 ("BRI") 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 BRI 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(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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), 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), except as otherwise indicated in an Office action.
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 5, 18 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 5 and claims dependent thereon, the limitation "wherein the first portion of the protective sheath comprises a peelable first side disposed on the first major side of the piece of porous sample collection media and a peelable second side disposed on the first major side of the piece of porous sample collection media" is indefinite. It is unclear to what a "side" refers in the context of the above-noted limitation. Specifically, the claim requires both of the peelable "sides" to be located on the same major side of the collection media, but differentiates these as "first" and "second" sides. It is unclear if the limitation is intended to require two peelable layers are provided on the same major side of the collection media, which is not illustrated in the drawings as noted in the objection(s) above, or if the limitation merely contains a typographical error. If the former, it is unclear how such an arrangement could reasonably be considered different (i.e., first and second) "sides," and/or how a protective sheath comprising the two recited sides is "fully covering the first major side and the second major side" as required by claim 1. The limitation as written in claim 5 is repeated in portions of the specification (e.g., pg. 2, lines 12-13; pg. 13, lines 31-34; etc.). However, other portions of the application as filed support the presumption that the limitation contains a typographical error (e.g., Fig. 2; pg. 6, lines 22-26; pg. 10, line 10 - pg. 11, line 4; etc.), suggesting the limitation was probably intended to recite the peelable second side is disposed on the second major side of the piece of porous sample collection media.
For the purpose of this Office action, claim 5 will be discussed with the understanding it contains a typographical error, and instead recites the peelable second side is disposed on the second major side of the piece of porous sample collection media, such that the peelable first and second sides fully cover the first and second major sides of the piece of porous sample collection media as required by claim 1. The examiner notes an amendment consistent with this interpretation would also overcome the objection(s) to the drawing discussed above.
Regarding claim 18 and claims dependent thereon, there is insufficient antecedent basis for the limitation "the exposed sample collection media" in the claim, as all previous references to the "sample collection media" refer to said media as "protected" rather than "exposed."
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0125333 A1 ("Alburty") in view of US 2014/0370585 A1 ("Zook").
Regarding claims 1, 5 and 7, Alburty discloses/suggests a protected sample collection media (Figs. 9, 14, etc., collection filter assembly 913, 1414, etc.) for use in a sample collection device (intended use; mask 900, 1400, etc.; ¶ [0073]; etc.), the protected sample collection media comprising:
a piece of porous sample collection media having a first major side and an opposing second major side (collection filter(s) 908 and/or 910, 1408, etc.); and
a protective sheath comprising a first side disposed on the first major side of the piece of porous sample collection media and a peelable second side disposed on the second major side of the piece of porous sample collection media, such that the protective sheath fully covers the first major side and the second major side (protective layers 906 and 912, 1406 and 1410, etc.), the protective sheath comprising a second portion forming a tab constructed to be gripped by hand (tabs 905 and 911, 1405 and 1409, and/or single combined tab, as described in ¶ [0120], etc.) and a first portion (remainder of protective layers 906 and 912, 1406 and 1410, etc., less the above-noted tab(s)).
Alburty does not expressly disclose the first portion is removable (e.g., peelable) without removing the second portion. However, as noted above, Alburty does disclose the protective layers defining the protective sheath may be bonded to have a single, combined "second portion" (e.g., ¶ [0120] single, combined tab), and further discloses the bond between the layers of the collection media (e.g., protective layers and collection filter(s)) may be removably bonded with a tear-away portion to allow for separation of the layers, including separating and discarding the protective layer(s) prior to storage and/or analysis (e.g., ¶ [0118]; ¶ [0153]; etc.).
Zook discloses a protected sample collection media comprising a sample collector (210; ¶ [0049]); and at least one protective layer covering at least one major side of the sample collector (barrier layer 370), wherein the protective layer comprises a first portion (portion of barrier layer 370 from tab 374 to perforation 372) separated by perforations from a second portion (portion of barrier layer 370 from perforation 372 through hinge region 345), wherein the first portion is peelable and removable without removing the second portion (e.g., ¶ [0051] hinge region allows barrier layer 370 to be lifted; ¶ [0050] perforation 372 permits the removal of at least a part (i.e., the above-noted first portion) of the barrier layer 370; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the protected sample collection media of Alburty with a separation between the first and second portions being marked by perforations, such that the first portion (e.g., non-tabbed portions of both protective layers) is peelable and removable without removing the second portion as taught/suggested by Zook in order to facilitate tearing away and discarding each layer of the protective sheath prior to storage and/or analysis of particles collected by the collection media (Alburty, ¶ [0118]).
Regarding claims 2-3, Alburty as modified discloses/suggests the protected sample collection media comprises a supportive frame disposed along the protective sheath, wherein the supportive frame extends along outer edges of the protective sheath (e.g., Fig. 14, support frame 141).
Regarding claim 4, Alburty as modified discloses/suggests the protective sheath comprises paper, plastic, metal, nonwoven sheet, or a combination thereof (e.g., ¶ [0117]; etc.).
Regarding claim 6, Alburty as modified discloses/suggests the first and second portions are integral with one another (Alburty, Figs. 9, 14, etc.; Zook, Fig. 3; etc.).
Regarding claims 8-9, Alburty as modified discloses/suggests the porous sample collection media comprises nonwoven material (¶ [0117]; ¶ [0152]; etc.), wherein the nonwoven material comprises polylactic acid, polypropylene, or a combination thereof (e.g., ¶ [0151] collection filter 1408 may be constructed from the internal filter material that is primary filter layer within the protective filter material 1401 of many N95 masks, which one of ordinary skill in the art would readily appreciate is and/or at least encompasses nonwoven polypropylene, as evidenced by, e.g., "N95 Respirator," mailed herewith).
Claim(s) 10-11 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alburty in view of Zook as applied to claim(s) 1-9 above, and further in view of US 2020/0397340 A1 ("Dweik").
Regarding claims 10-11 and 13-15, Alburty as modified above discloses/suggests a sample collection system comprising: the protected sample collection media of any one of the preceding claims (see discussion of claims 1-9); and a sample collection device comprising an airflow path extending from a first end to a second end (e.g., Figs. 56A-B tube), wherein the first end forms a mouthpiece (e.g., ¶ [0073] the tube can be placed in the mouth). Alburty as modified does not disclose the sample collection device comprises an opening constructed to receive the protected sample collection media such that the piece of porous sample collection media occludes the airflow path and the tab at least partially extends outside of the sample collection device.
Dweik discloses a sample collection system comprising a protected sample collection media (e.g., Fig. 5, filter assembly 27) including, inter alia, a piece of porous sample collection media having a first major side and an opposing second major side (filter 73) and a tab constructed to be gripped by hand (rounded proximal end 87; ¶ [0075]); and a sample collection device (body 21) comprising an airflow path extending from a first end to a second end (Fig. 3b, fluid channels 37 and 43), and an opening or slot constructed to receive the protected sample collection media (cavity 49 and/or transverse opening 51; ¶ [0068]) such that the piece of porous sample collection media occludes the airflow path and the tab at least partially extends outside of the sample collection (e.g., Fig. 2a; ¶ [0082] while mounted within cavity 49, filter 73 is preferably positioned between and aligned with fluid channels 37, 43), wherein the sample collection device comprises a tubular wall defining the first end and the second end (e.g., Fig. 2b, 3a, etc.), wherein the opening is an opening formed between two parts of the tubular wall (e.g., Fig. 3b, where opening/cavity 49 is defined between distal end 42 of proximal portion 31 and proximal end 46 of distal portion 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of Alburty with a tubular wall defining the first end and the second end, and a opening, such as a slot, constructed to receive the protected sample collection media such that the piece of porous sample collection media occludes the airflow path and the tab at least partially extends outside of the sample collection device, wherein the opening/slot is in the tubular wall and formed between two parts thereof, as taught and/or suggested by Dweik in order to enable selectively securing the protected sample collection media to the sample collection device for collection of (e.g., Dweik, ¶ [0068] and/or as a simple substitution of one suitable arrangement for selectively combining a protected sample collection medium with a sample collection device for collection of particles exhalated through the sample collection device for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alburty in view of Zook and Dweik as applied to claim(s) 10 above, and further in view of US 8,833,369 B2 ("Dolezal").
Regarding claim 12, Alburty as modified discloses/suggests the limitations of claim 10, as discussed above, but does not disclose the slot is disposed at a non-perpendicular angle relative to the airflow path.
Dolezal discloses disposing a filter media at a non-perpendicular angle relative to the airflow path may increase the surface area of the filters (e.g., col. 16, line 64 - col. 17, line 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of Alburty with the slot being disposed at a non-perpendicular angle relative to the airflow path in order to afford increased area available for filtration/sample collection (Dolezal, col. 16, line 64 - col. 17, line 28).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alburty in view of Zook and Dweik as applied to claim(s) 13 above, and further in view of US 4,00,7024 A ("Sallee").
Regarding claim 16, Alburty as modified discloses/suggests the limitations of claim 13, as discussed above, but does not disclose the tubular wall comprises a track on an inside surface of the tubular wall constructed to guide or support the protected sample collection media.
Sallee discloses a wall defining a first end and a second end (conduit 20) comprising a track on a inside surface thereof (track 18; cooperating tracks; etc.) constructed to guide or support a sample collection medium (col. 1, lines 9-41, filter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of Alburty with the tubular wall comprising a track on an inside surface of the tubular wall constructed to guide or support the protected sample collection media as taught/suggested by Sallee in order to utilize a conventional arrangement for removably supporting the collection medium within the sample device (Sallee, col. 1, lines 9-41) and/or as a simple substitution of one suitable arrangement for supporting the sample collection medium within a sample collection device for another to yield no more than predictable results. See MPEP 2143(I)(B).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alburty in view of Zook and Dweik as applied to claim(s) 10 above, and further in view of US 2016/0022946 A1 ("Sislian").
Regarding claim 17, Alburty as modified discloses/suggests the limitations of claim 10, as discussed above, but does not disclose the sample collection device is constructed for coupling with a sample collection tube via a bayonet coupling, interference fit, snap fit, or threaded coupling.
Sislian discloses/suggests a sample collection device (cartridge module 10 including a sample reservoir 18 and medium therein), wherein the sample collection device is constructed for coupling with a sample collection tube (¶ [0054] dispensing mechanism allows integration of the cartridge module for transfer of the sample into a standard use tube, vial, or any other receptacle). Dweik discloses a snap fit as a suitable removable coupling mechanism between two components (e.g., ¶ [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collection device of Alburty to be constructed for coupling with a sample collection tube via a bayonet coupling, interference fit, snap fit, or threaded coupling as taught/suggested by Sislian and Dweik in order to facilitate transferring the sample media (e.g., piece of porous sample collection media) to a collection tube without requiring manual removal of the protected sample collection media, in a manner that better isolates the collection media from the outside environment (Sislian, ¶ [0054]), etc.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alburty in view of Zook and Dweik as applied to claim(s) 10 above, and further in view of US 2023/0141831 A1 ("Chun").
Regarding claims 18-20, Alburty as modified with respect to claim 10 discloses/suggests a kit for collecting a sample, the kit comprising the sample collection system of claim 10, but does not expressly disclose the kit comprises instructions.
Chun discloses a kit for collecting a sample comprising a sample collection system and instructions (e.g., ¶¶ [0237]-[0245] sampling kit including collection tool and an instruction manual on how to use the sampling kit to collect a specimen, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of Alburty to include instructions for use of the sample collection system as taught and/or suggested by Chun in order to enable a user to perform sample collection according to appropriate procedures (Chun, ¶ [0248]).
The limitations of claims 18-20 directed to the content of the kit instructions are printed matter (i.e., to the content of information). This printed matter is not functionally or structurally related to the associated physical substrate, i.e., the sample collection system, and is therefore owed no patentable weight. See MPEP 2111.05 (e.g., "For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864"). Accordingly, Alburty as modified discloses/suggests the limitations of claims 18-20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791