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 Arguments
Applicant's arguments/amendments filed April 4, 2026 have been fully considered but they are not persuasive relative to the 112 rejections. See rejections herein. Applicant’s arguments, with respect to the art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2011/0280863; Buhimschi; Catalin S. et al.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the method claims (1, 4-7, and 20) are defined by the positively claimed steps listed in the body of the claim and the apparatus (claims 8-10, 13-18, and 21-23) is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that although the apparatus claims mention misfolded protein, aggregate of the misfolded protein, a biological sample, mixed liquid, and detection reagent none of such are positively claimed as structural elements of the apparatus. All of the prior are materials and/or articles intended to worked upon or can be used with the apparatus. The apparatus is not defined by any method steps and is not required to be used in any method at all. The apparatus is not defined by the possible uses nor intended use of the entire apparatus nor individual structural elements of the apparatus.
The apparatus of claim 8 is only structurally defined by:
a housing defining a fluid separation chamber; and
a fluid collection chamber;
wherein, the fluid separation chamber contains a separation matrix constructed to adsorb the detection reagent (not claimed as an element of the apparatus nor defined as any specific material, substance, etc.).
It is noted that various “used to…”; “to allow…”; and similar clauses recited in the apparatus claims are directed to intended, possible use with the unclaimed materials noted above. There is no requirement for the apparatus to ever be used in any method, to perform any process steps relative to any of the unclaimed materials nor any method at all.
Furthermore, it is noted that the method of claim 1 does not require the use of a same apparatus as that defined in claim 8. The method claims do not recite who and/or what is required employed to perform each of the steps (providing, mixing, enabling, collecting, detecting, etc.). There is no structure recited that is employed to perform each of the steps (no structure claimed that provides any mixing, motive forces of flowing anything, etc.).
It view of the phrase “free liquid state” it is presumed that the biological sample and detection reagent are liquids.
Furthermore, it is noted that the biological sample of the method of claim 1 is not required to contain a misfolded protein. There is nothing precluding the biological sample from including a substance that is capable of binding with the detection reagent such that the detection reagent passes through the separation matrix. Thereby, allowing the detection reagent in the collected sample that I bound to a different material than the misfolded protein to be detected. Therefore, the separation matrix will not necessarily adsorb all detection reagent not bound to the misfolded protein. Therefore, the detection of detection reagent does no necessarily mean a misfolded protein is present in the collected sample. The claim does not account for such.
It is noted that what method(s) (claim 23) can be used “an optical method” (not defined in the claim by any specific steps) is not a structural element of the apparatus.
Claim Objections
Claim 8 is objected to because of the following informalities: the claim is not drafted according to US practices such that each of the positively claimed elements are listed on separate indented lines. 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 1, 4-7, 9, 18, and 20-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the detection reagent that does not bind to the misfolded protein or the aggregate thereof" in (c). There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of nor step that requires any detection reagent to bind and not bind to the misfolded protein nor anything.
Claims dependent claims 4-7, and 20 are rejected via dependency upon a rejected claim.
As to claims 9 and 21-22 it is unclear what is further required by the claims because the claims do not provide for any additional structural element nor further structural limit and prior positively claimed structural element. Instead the claims are directed and biological sample that are not structural elements of the apparatus. See claim interpretations.
As to claim 18, it is unclear what is the structural nexus, connectivity of the fluid receiving chamber to previous fluid separation chamber and fluid collection chamber because the claim does not provide for such. Furthermore, it is noted that there is no structure distinction between the fluid separation chamber, fluid collection chamber and the fluid receiving chamber. The names of the chambers do not provide for any further structural elements of the chambers. The names of the chambers are directed to intended use of the chambers. Both of the fluid separation chamber and fluid collection chamber are structurally capable of receiving the biological sample.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4-10, 13-18, and 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al, CN108291905A (US 11,073,516) in view of US 2011/0280863; Buhimschi; Catalin S. et al.
Davies discloses a diagnostic method and device for detecting at least one protein in a biological sample of a mammal, wherein the device comprises: a) a sample receiving material for receiving (providing) a biological sample; b) a detection reagent that reacts with (is mixed with or binds to) at least one protein present in the biological sample; c) a trap (equivalent to a fluid separation chamber or a separation matrix), wherein the trap is in contact with the sample receiving material and separates the detection reagent that binds to the at least one protein in the biological sample from the detection reagent that does not bind to the at least one protein in the biological sample (adsorbs the detection reagent that does not bind to a misfolded protein or an aggregate thereof from a mixed solution), thus the detection reagent that binds to the at least one protein in the biological sample can flow through the trap (the detection reagent that binds to a misfolded protein or an aggregate thereof is allowed to flow through the trap), and thus the trap captures the detection reagent that does not bind to the at least protein in the biological sample; and d) a capillary bed, wherein the capillary bed is in contact with the trap, and is configured to contain the biological sample after the biological sample flows through the trap. The sample receiving material (separation layer), the trap and the capillary bed are configured to be in contact in sequence, and the capillary bed displays (indicates) the detection reagent if at least one protein is present in the biological sample.
At least one protein is selected from a group consisting of misfolded proteins, protein aggregates, misfolded protein fragments and protein aggregate fragments. Davies discloses a housing for packaging the diagnostic device (implicitly disclosing that the housing defines a fluid separation chamber and a fluid collection chamber).
The housing or cassette may comprise a well (or other entity) (collection chamber) for biological sample application and may also contain a window for reading the results obtained. (US 11,073,516 column 3, lines 35-40).
As to claims 6, 9-10, 15-17, and 21, the detection reagent is a dye, such as Congo red and the separation matrix comprises cellulose and polymer, such as polysulfone.
Davies discloses a kit for detecting a target protein in a sample, wherein the kit contains a device for detecting misfolded proteins associated with preeclampsia present in a sample from a pregnant mammal (the use of the device in the preparation of a kit for diagnosing or predicting a disease characterized by misfolded proteins). Misfolded protein disorders are selected from a group consisting of preeclampsia, Alzheimer's disease, prion disease and Parkinson's disease. (paragraphs [0001] - [0190], and figures 1-5).
Davies does not disclose collecting, in a free liquid state, the biological sample passing through the separation matrix, in a fluid collection chamber, i.e., the collected biological sample can freely flow in the fluid collection chamber that does not provide for capillary action.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Buhimschi discloses an apparatus and method of assessing or estimating the risk that a pregnant woman will have (will develop) preeclampsia comprises: (a) obtaining a urine sample or a placental tissue sample from the pregnant woman; (b) combining the sample with a dye (e.g., Congo Red) that stains at least one protein or protein fragment present in misfolded protein aggregates associated with preeclampsia, under conditions under which the dye stains proteins in the sample, thereby producing a sample that further comprises the dye; and (c) analyzing the urine or placental tissue sample produced in (b) for the presence of (determining if the sample contains) misfolded protein aggregates associated with preeclampsia stained with the dye, wherein if the sample contains misfolded protein aggregates associated with preeclampsia stained with the dye, the woman is at greater risk of developing (has an increased risk of developing) preeclampsia than if the sample does not contain misfolded protein aggregates associated with preeclampsia stained with the dye. Detection of stained aggregates can be carried out using known methods, such as dot blot analysis or simple visualization of an area of a stained surface (e.g., on a surface, such as filter paper) that comprises the urine or placental tissue sample combined with the dye (e.g., urine combined with Congo Red). (paragraph 0025).
As to claims 1, 4-5, 8, 13-14, and 22, the samples may be analyzed immediately after collection (e.g., on a dot blot, dipstick or similar) or at a later time. For example, the urine samples may be frozen at −70° C. and/or collected in a tube or vessel. (sample collection chamber; paragraphs 0140, 195).
The method of detection employed can be an optical based method using various labeling and/or detection systems known (fluorescent, chemiluminescent, spectrometry (paragraphs 0140, 157, 199, 224)
It would have been obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention to provide for a an optically, light transmissive collection chamber (vessel, tube, container, etc.) as taught by that allows for free liquid flow of and optical detection of a collected sample, to which the collected sample is not attached to, and that does not provide for capillary action as such does not require any special knowledge and skills beyond that of one ordinary skill. Furthermore, it is noted that providing for or not providing for capillary forces is an obvious matter of design choice and such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
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 BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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