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 .
Election/Restrictions
Newly amended submitted claims 5-13 and 16-17 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The method of claim 1 is directed to a method performed by broad, structurally undefined “processing unit”. The method of claim 1 does not require any step that uses a label comprising a surface for fixing to a cartridge; and an opposite surface defining at least one identification region, readable by a communication interface of a microfluidic processing unit, including one or more processing parameters used for adapting a processing of a biological sample contained the cartridge. (claim 5) The method of claim 1 does not require any step that uses a cartridge (as defined in claim 11) comprising: a sample chamber for containing a biological sample to be processed by a microfluidic processing unit according to one or more processing parameters; and at least one identification region, readable by a communication interface of the microfluidic processing unit, including one or more processing parameters for adapting a processing of the biological sample contained in the cartridge.
Therefore, the method of claim 1 does not provide for corresponding special technical features (structures) of those of claims 5 and 11. Furthermore, claims 5 and 11 do not require any corresponding technical features (steps) of claim 1. Had the amended claims been originally filed, lack of unity would have been found.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 5-13 and 16-17 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant's arguments filed July 9, 2026 have been fully considered but they are not persuasive.
It is noted that applicant amended the claims, but fails to provide for the text of the originally filed specification that supports (describes) the amendments. It is hereby requested that applicant provide for the specific text of the specification that describes all amendments.
The claims have not been amended to sufficiently address the prior and further 112 issues. See remarks and 112 rejections herein.
Claim 1 as drafted does not provide for any step that requires the processing unit nor anything/anyone to perform “adapting processing parameters”. Therefore, it is unclear how the method as defined by the steps listed in the claim after the transitional phrase provide for, define "a method for adapting processing parameters." (See further 112 rejections herein).
As to the art rejection, applicant asserts:
“Kusner discloses a microfluidic cartridge (100) that includes a tag (198) that carries a code "to provide identifying information related to the microfluidic cartridge". [0082] Kusner describes that information as "at least information relating to the position of a microfluidic cartridge 100 within a molecular diagnostic system, and information relating to samples analyzed using the microfluidic cartridge 100 (e.g. how many positions remain available for conducting tests)." Id. In alternative variations, the tag may relate other information about samples (e.g. sample type, sample volume, sample concentration, date) processed using the microfluidic cartridge 100". None of this information on the tag of Kusner relates to adapting a processing of the sample(s) within the cartridge. As expressed by Kusner, "Other embodiments of the microfluidic cartridge 100 may further comprise tag 198"( 0082]) - i.e., the tag is optional. Again, as expressed by Kusner: "Alternatively, the microfluidic cartridge 100 may not comprise a tag 198, and a user or other entity may relate identifying information to the microfluidic cartridge 100 using any appropriate element". Ultimately, the tag of Kusner simply identifies the cartridge and/or the sample contained therein. Notably, the rejection does not make any reference to the method steps of claim 1, but instead focuses on the cartridge of Kusner having a tag. For instance, the rejection does not indicate how the tag of Kusner is read or how the biological sample is processed.
To the extent that the rejection of independent claim 1 has not properly considered the steps of the method, the clarifying amendment should make clear that the claimed method requires reading the processing parameters from the identification, adapting the process according to those parameters and them performing the adapted process on the biological sample. At a minimum, Kusner does not disclose adapting the processing of the biological sample based on information read from the tag (198). Again, as noted above, the tag simply relays information about the cartridge or the sample, but not about how the sample is to be processed in advance of the sample being processed. Consequently, Kusner cannot anticipate independent claim 1 or any of its dependent claims 2-4.”
The examiner disagrees. As acknowledged by applicant the cartridge 100 includes a tag 198 (an identification is provided applied to the cartridge) information about samples (e.g. sample type, sample volume, sample concentration, date) processed using the microfluidic cartridge 100. The information is “processing parameters” including a sample “type” as recited in applicant’s claim 3. The tag 198 is read by “an optical machine” (barcode reader which is a conventionally known device in the art along with other known electronic, optical readers i.e., scanners, cameras, etc. as also taught in the references previously cited on the 892) (paragraph 0082).
As to how the biological sample is processed, applicant’s claim 1 does not provide for any specifics as to “how” the biological sample is processed. Furthermore, the method of claim 1 is recited as “a method for adapting processing parameters” as recited in the preamble and the processing parameters are for processing a biological sample. The method as recited in preamble is not a method of processing a biological sample. See further remarks and rejections herein. However, Kusner clearly states the invention is for “molecular diagnostics” including DNA and RNA analysis and the sample is (analyzed) processed using the microfluidic cartridge and that disclosed the reference (processing unit). The particular analysis performed may be either qualitative and/or quantitative. Methods of analysis may involve isolation, purification, and amplification of nucleic acid materials, and polymerase chain reaction (PCR) is a common technique used to amplify nucleic acids. Often, a nucleic acid sample to be analyzed is obtained in insufficient quantity, quality, and/or purity, hindering a robust implementation of a diagnostic technique. Current sample processing methods and molecular diagnostic techniques are also labor/time intensive, low throughput, and expensive, and systems of analysis are insufficient. Furthermore, methods of isolation, processing, and amplification are often specific to certain nucleic acid types and not applicable across multiple acid types. Due to these and other deficiencies of current molecular diagnostic systems and methods, there is thus a need for improved devices for processing and amplifying nucleic acids. Thus, there is a need in the molecular diagnostics field to create an improved microfluidic cartridge to facilitate processing and detecting of nucleic acids. This invention provides such a microfluidic cartridge. See the entire reference including, but not limited to paragraphs 0004-05. The information related to the sample is not simply employed to identify the sample. The information governs what diagnostic protocol(s) will be performed to samples in the microfluidic cartridge (adapting processing of the biological sample and processing the biological sample in the cartridge) based upon the information (processing parameters) provided for by the tag. Thus, why such information (specific patient information that the biological sample is obtained from; and further information about the sample…amount, type, etc. ) is relayed from the tag.
Therefore, the claims are rejected as given herein.
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 positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
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 inventions are defined by the positively claimed steps (claim 1) a listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that a “processing unit” and “identification” are not structurally defined in the claims as being any specific structure(s).
Furthermore, it is noted that a “processing parameter” (of what?) is not defined in claim 1. Furthermore, “processing” and “adapting the processing” are not specifically defined so as to determine what is required to be done to be considered as such.
It is noted that claim does not recite who/what performs “providing an identification on a cartridge”.
It is noted that the phrase “one or more” only requires one.
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 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.
As to claim 1, the method is defined by the positive claimed steps listed in the body of the claim, not what is recited in the preamble of the claim. Although the preamble recites “a method for adapting processing parameters for processing a biological sample”, there is no step listed in the claim that requires anyone nor anything to perform any broad “adapting” any broad, undefined, and unspecified “processing parameters”. Therefore, it is unclear what is required to be done (by who/what) to be considered as “adapting processing parameters” because the claim does not provide for such.
Claim 1 recites the limitation "one or more processing parameters adapted to the biological sample" in the first paragraph. There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of nor step that requires any adapting one or more processing parameters to the biological sample”. Furthermore, it is unclear what is the nexus of the “one or more processing parameters” to the previously recited “processing parameters” because the claim does not clearly provide for such.
Furthermore, it is unclear what is meant and required by the phrase “the processing unit performing the processing according to the processing parameters” now recited in the preamble because it is unclear if such refers to the previously recited “adapting” and/or “processing a biological sample” recited in the preamble. The examiner presumes the latter. However, although such is not a step that defines the invention, such phrase appears to be redundant because the preamble previously states “processing a biological sample using a processing unit”. It is noted that such phrase cannot define or refer to a later recited step. If such phrase, the last “performing” step, then such is improper.
The claim is confusing. Although the preamble recites “a method for adapting processing parameters”, it appears that the claim is also directed to “processing a biological sample” as indicated by the preamble and the last paragraph/step reciting “performing the processing”. Therefore, the preamble is misleading and inaccurate because the method steps are not solely directed “adapting processing parameters”. There is no step recited in the body of the claim that requires and “adapting processing parameters” nor is there any step recited that requires anyone nor anything (including the processing unit) to do anything to be considered as “adapting” any intangible processing parameters. All of the steps that are intended to define the method should be clearly listed on separate indented lines in the body of the claim after the transitional phrase “comprising”. However, it is noted that none of the current recited steps requires “adapting processing parameters”. There is no indication as to who or what is required to perform the “providing” (applying a label in claim 2). It is unclear what is the nexus of the processing parameters recited in the preamble and the “one or more processing parameters” to the unspecified “identification” because the claim does not recite such. Furthermore, it is unclear how the reading is performed because the one or more processing parameters (not structure) are not claimed as being elements of the cartridge nor elements of the identification (located in/on the cartridge and/or identification).
The phrase “one or more parameters adapted to the biological sample” is past tense. However, there is no prior step recited in the claim that requires the processing unit to perform “adapting one or more processing parameters…” The using step requires the processing unit to read “the one or more processing parameters” and “adapting the processing of the biological sample” which is not defined as adapting any processing parameters. The last “performing” step, presumptively performed by the processing unit (see preamble) is directed to performing the adapted processing of the biological sample not adapting any process parameters. Therefore, it is unclear how the steps define a method for adapting processing parameters as recited in the preamble.
There is no indication as what is required to be done by who/what to be considered as “processing”, what is required to be done to such processing to be considered as “adapting the processing of the biological sample…“ and what is required to do to be considered “processing, as adapted, of the biological sample in the cartridge by the processing unit” because the claim does not clearly recite such. It is unclear how the “performing” modifies defines the “method of adapting processing parameters” because such is not directed to “adapting” (doing anything to) any processing parameters. The performing step does not require anyone nor the only broad, structurally unspecified processing unit to do anything specific to any processing parameters nor to the biological sample.
Anything done to the broad, biological sample can be considered as “processing”. This is also applicable to further claims reciting adapted and/or adapting any broad processing parameters.
Claim 1 recites the limitation " the biological sample of one or more processing parameters adapted to the biological sample”" in the paragraph beginning with “providing”. There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of a biological sample being “of” one more processing parameters nor any one or more processing parameters comprising a biological sample. Therefore, it is unclear what is meant/required by the phrase “the biological sample of one or more processing parameters adapted to the biological sample”. Furthermore, there is no prior step requiring adapting one or more parameters to the biological sample. (Also applicable to claim 3). There is no mention of what is required be done to one or more parameters for such to be considered as “adapted to the biological sample”. Therefore, it is unclear what is meant, required by “one or more processing parameters adapted to the biological sample” and how the method provides for “adapting processing parameters” as recited in the preamble because there is no step claimed that requires anyone nor anything to perform “adapting” any processing parameters.
It is unclear how the one or more processing parameters is required to be read from the cartridge because it has not been previously established that the cartridge has/comprises a readable processing parameter. It would appear that the “identification” can be read rather than any intangible processing parameter that has not be established as being an element of the cartridge.
Claim 1 recites the limitation "the processing parameter" in the last line of the second paragraph. It is unclear which/what processing parameter is being referenced by the clause because the previously recites “processing parameters” and “one or more processing” parameters.
Furthermore, it is unclear what is required to be done by the processing unit to be considered as “adapting the processing depending on the processing parameter” because the claim does not clearly recite such. There is no prior step that requires performing any unspecified “processing” of anything. Such “processing” (presumptively, intended to be defined by actual steps required to be performed by someone or something to the biological sample) is not defined in the claim. Furthermore, there is no indication as to what is required to be done to such “processing” to be considered as “adapting the processing”. It is unclear how such processing can be referenced as such in the paragraph, before defining the processing, requiring the processing to actually be performed.
Claims 2-4 are rejected via dependency upon a rejected claim.
Claim 2 recites the limitation " the cartridge that includes at least one identification region having the one or more processing parameters " . There is insufficient antecedent basis for this limitation in the claim. The cartridge has not been claimed as comprising (including) at least one identification region having the one or more processing parameters”.
As to claim 2, It is unclear what is structurally required to be considered “at least one identification region” because such is not structurally defined in the claim. There is no indication as to what are the structural boundaries, dimensions of the at least one identification region” so as to structurally distinguish such region from any other structure or “region” of the cartridge. One can name any location (not defined by any specific structure nor definitive boundaries), “region” of anything as one so desires.
Claim 2 is confusing in view of claim 1 because claim 1 does not require a label for an identification to be present on the cartridge. If the identification is already present it is unclear what is the point for further applying a label to the cartridge when such label is not required to contain to be nor contain the identification. Therefore, it is unclear how applying the label is considered as defining providing the identification on the cartridge. Furthermore, it is unclear how the “at least one identification region has the one or more processing parameters”. The processing parameters are not tangible structures. The claim is not consistent with the prior version of the claim nor specification because the prior version of the claim and specification recites the at least one region is “for” a processing parameter not that the at least one region comprises, has a processing parameter as claimed. The specification describes such region as comprising markings, wording, encoding, QR codes, etc. that when read can provide for encoded information (processing parameters), but the at least one identification region does not “have” the intangible one or more processing parameters as claimed.
It is unclear what is further required by claim 3 because the claim is not directed to any further step nor limits any prior claim step. As stated above, there is no step that requires “adapting” one or more processing parameters. Furthermore, there is no indication as to what is required to be done to a processing parameter to be considered as “adapted with respect to sample type of the biological sample” because the claims do not provide for such.
As to claim 3, see prior rejection of claim 1. Furthermore, it is noted that “a sample type” relative broad. What one chooses to refer to as a “type” is subjective. No such type is clearly defined in the claim. Any biological sample can be considered as a “type” of biological sample.
Claim 4 does not provide for any required step, the prompting is conditional upon an event that is never required to occur. However, it is unclear what is required to occur, not occur for a reading to be considered “unsuccessful” or “successful” because the claim does not provide for such. Furthermore, it is noted that what intangible “processing parameter” that a user may choose to enter is not required to be amongst, same as any of the unspecified “one or more parameters”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Kusner et al, US 2018/0066248.
Kusner discloses a device and method for processing samples in a microfluidic cartridge via a diagnostic system/module that reads a tag on the cartridge to adapt processing of the cartridge depending on reading of the tag.
The microfluidic cartridge 100 may further comprise a tag 198 (at least one identification region/label, cartridge identifier on a surface of the cartridge) that functions to encode and provide identifying information related to the microfluidic cartridge 100. The tag 198 may comprise a barcode, QR code, or other optical machine-readable tag, or may alternatively be an electronic tag, such as an RFID chip. (which include code; claim 9). The identifying information (for processing parameters) preferably comprises at least information relating to the position of a microfluidic cartridge 100 within a molecular diagnostic system (processing unit/communication interface), and information relating to samples analyzed using the microfluidic cartridge 100 (e.g. how many positions remain available for conducting tests). In alternative variations, the tag may relate other information about samples (e.g. sample type, sample volume, sample concentration, date) processed using the microfluidic cartridge 100. Preferably, the tag does not interfere with procedures being performed using the microfluidic cartridge, and is located in an unobtrusive position on the microfluidic cartridge 100, such as a side panel of the microfluidic cartridge 100. (paragraph 0089; see also Figures including 11A).
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shah et al., US 20210069719 A1.
Shah discloses a tissue (type of biological sample) processing system (processing unit) for processing a laboratory slide comprises a cartridge receiving area configured for releasably receiving a cartridge comprising individual wells, each well enclosing a fluid for processing the slide; means for moving the cartridge receiving area to align an outlet port of each individual well with the slide, or vice versa; and a reader for reading a code printed (identification/label applied) on the cartridge, the code containing processing instructions (processing parameters) for the cartridge. The system is configured to dispense fluid from the outlet port of each well of the cartridge based upon the code printed on the cartridge (adapting and performing the processing of the biological sample). (paragraph 0007).
A user interface 17 comprising a keypad, buttons and/or a display is disposed on the front side of the enclosure for receiving commands and information input by an end user or operator of the system 10. The user interface 17 is connected to an internal computer 23 including a processor and a controller for operating the system 10. The computer 23 is also electrically connected to the motors, RFID/barcode readers, pumps, compressors, heating element, solenoids and sensors, which are described herein, to send/receive signals to/from those components. (paragraph 0035).
A barcode or RFID label 27 (FIG. 8) is disposed on the top surface of the cartridge 20, and a barcode or RFID reader 29 is disposed on the system 10 for reading the barcode or RFID label 27 of the cartridge 20. The label 27 (identification/label provided/applied on an identification region) on the cartridge 20 contains information (processing parameters) for processing of a slide, e.g., procedure type (e.g., melanoma analysis), sample type, processing times, temperature, protocols, expiration date etc. The system 10 may further include a barcode or RFID label disposed on the top surface of the slide 14, and a barcode or RFID reader 31 mounted in the enclosure 18 for reading the barcode or RFID label of the slide 14. The label on the slide 14 may contain information (processing parameters) related to the slide 14, e.g., procedure type, sample type, patient data, processing times, temperature, protocols, etc. The computer 23 is configured to compare the information from the slide 14 and the cartridge 20 (based upon the information inputted from the labels) to determine whether the procedure type for the cartridge 20 matches the procedure type for the slide 14. The system 10 is further configured to alert an end user if the procedure types do not match, (adapting the processing based on a processing parameter and prompting a user, claim 4) which may signify that an incorrect cartridge 20 was installed in the system 10. (paragraph 0035; see also 0080, 89, 92-93).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Eberhart; David et al.; Andeshmand; Sayeed et al.; FIGUEREDO; Marcus Vinicius Mazega et al.; Birrer; Armin et al.; Iqbal; Shazi S et al.; SILBERT; ROLF et al.; NIELSEN; William D. et al.; Frank; Paul et al.; BURGART; Lawrence J. et al.; Bjerke; Michael P. et al. and O'Banion; Matthew et al. disclose methods employing cartridges including identifications.
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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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