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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 13, 2026 has been entered. The amendments have been thoroughly reviewed and entered. Any previous objection/rejection not repeated herein has been withdrawn.
New and/or modified grounds for rejection, necessitated by the amendments, are discussed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The instant rejection reflects the Guidance published in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidelines (Vol. 84, No. 4, Monday January 7, 2019 at 50) and the October 2019 Updated Subject Matter Eligibility Guidance (hereinafter both referred to as the “Guidance”).
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Are the claims directed to a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea (Prong One); If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims recite additional elements that amount to significantly more than the judicial exception.
Framework Analysis as Pertains to the Instant Claims:
With regard to (1), the instant claims recite a “method for load balancing specimen containers between a plurality of automated detection apparatuses” and therefore the answer is "yes".
With regard to (2A), Prong One, under the broadest reasonable interpretation (BRI), the instant claims recite steps directed to the judicial exception of an abstract idea type, that falls within the group including “mental process” (See MPEP 2106.04(a)(2) subsections (I) and (III)) because said operations could be performed in the mind (which includes data gathering, determining, and application of mathematical concepts), which are also abstract ideas under 35 USC 101.
The method steps remain an abstract idea. The abstract idea includes the application of vague data gathering, determinations and transfer steps based on calculations by the system controller.
The new step of detecting the presence of a specimen container at a container pick-up station located at the first detection apparatus by one or more sensors connected to the system controller, is undefined and at best considered a data gathering step which is well-known, routine and conventional in the automatic analyzer art, see at least para [0072] of Bishop et al., (US 2011/0124038-already of record and discussed further below; hereinafter “Bishop”). Specifically Bishop teaches a system controller can be used to operate a transport mechanism based on a signal (e.g., a light sensor) indicating the presence, or absence, of one or more specimen containers at the loading station 202, wherein the transport mechanism includes a robotic transfer arm with a container gripping means that can pick-up and transfer at least one container into a holding structure or rack within the detection system (Bishop- para [0011] et seq.).
The system controller is recited at such a high level of generality that is unclear how determines a loading ability of the first automated detection apparatus, determines a loading ability of the one or more downstream automated detection apparatuses, determines a transfer status of the first automated detection apparatus and downstream apparatuses, determines the cell availability of the first and downstream apparatuses, to control a transfer mechanism used to transfer specimen container to downstream detectors based upon unknown determining steps and calculating a first ratio of available cell count to capacity in the first automated detection apparatus is less than a second ratio of total available cell count to total capacity of the first automated detection apparatus and the one or more downstream automated detection apparatus, wherein the available cell count and capacity are determined at least in part by the loading ability and transfer status of the first automated detection apparatus, and wherein the total available cell count and total capacity are determined at least in part by the loading ability and transfer status of the first automated detection apparatus as well as the second loading ability and second transfer status of the downstream automated detection apparatus .
Because the claims are directed to abstract ideas, they must further be analyzed under Prong Two to determine if said judicial exceptions are integrated into a practical application as determined by further assessment of the “additional steps” recited in the claims. With respect to Prong Two, the additional elements and the rationale pertaining to why the additional elements are not integrated, are as follows:
(a) amended claims now recite multiple steps using a generic system controller to perform the equivalent to mental steps (judicial exception). The amended claim 1 recites using a transfer mechanism comprising a robotic arm to transfer the specimen container from the first automated detection apparatus to one of the downstream automated detection apparatuses. These additional steps amounts to an equivalent of “apply it” in regards to the judicial exception. The lack of specificity as to how the system controller determines, calculates and executes the method steps is further evidence of judicial exception (see MPEP 2106.05(f));
(b) the plurality of automated detections apparatus and system controller are recited at a high level of generality. Note: the recitation that the each of the plurality of automated detection apparatuses comprises a housing, holding structure with a plurality of cells (holding units) configured to hold a specimen container is as a generic and well-known structure), such that the machine or apparatus used to apply the judicial exception is not a particular machine or apparatus (see MPEP 2106.04(a)(2)(III)(C) and MPEP 2106.05(b)).
As such, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea.
Because the claims fail under (2A), the claims are further evaluated under (2B). The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception under (2B) because, as discussed above with regard to integration of the recited abstract idea into a practical application, the additional elements herein amount to no more than an analytical laboratory/laboratory instruments and generic computer elements (system controller), which does not provide an inventive concept as a generic analytical laboratory/laboratory instruments with generic system controller is well-understood, routine and conventional. With regards to the generically recited system controller operatively connected to the at least one or more sensors that detect the presence of the specimen container at the first automated detection apparatus, these are well-understood, routine, and conventional components that are well-known in the art of automated detection systems, as demonstrated by Bishop et al., (US 2011/0124038; hereinafter “Bishop”; already of record). Bishop teaches a system and method of balancing a specimen container between a plurality of detections apparatuses a plurality of detection apparatuses means for automated loading, robot arm transfer and/or distribution of a specimen container.
Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because (1) the system controller is recited (somehow) determines a plurality of analytical laboratory/laboratory instruments are all being used in their ordinary capacity and are merely tools to execute the abstract idea (See MPEP 2106.05(d)), (2) the additional claim elements of determining/calculating information, whether considered individually or as a whole, do not meaningfully limit the judicial exception (See MPEP 2106.05(e)), (3) the claims recite insignificant extra-solution activity. The claims directed to a method using a plurality automated detection apparatuses (wherein the first detection apparatus includes at least one sensor to detect the presence of the specimen container at the first container pick-up station), each detection apparatus have a housing, holding structures configured to the hold the sample container linked to a system controller presumably for data gathering, determining and calculating well-known and conventional detection apparatuses, (See MPEP 2106.05(g)). Note: that MPEP 2106.04(a)(2)(III)(C) states that methods of performing a mental process on a generic computer, performing a mental process in a computer environment, or using a computer as a tool to perform a mental process are all claims that recite a mental process. Amended claim 1 recites a generic system controller that is used for data-gathering/determining/calculating and transferring containers among a plurality of detection apparatuses. This is using a generic computer as a tool to perform mental processes.
The dependent claims 2-7 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the features represent an abstract idea (including determinations by a system controller). Claims 2-7 amount to no more than determining information used to calculate the transfer of the specimen among a plurality of detecting apparatus, which is an intangible abstract idea, based upon data gathering, determinations and calculation of ratios performed by a generic controller. Therefore, the claims do not integrate the exception into a practical application or include additional elements that amount to significantly more. Thus, in light of the above considerations all of the claims are non-statutory, and thus not patent eligible under 35 U.S.C. 101.
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 1-7 remain 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.
Amended claim 1 recites a system controller included in the at least one or more the automated detection apparatuses (which as claimed does not include the first detection apparatus as it is distinct from the one or more downstream automated detection apparatuses). Claim 1 recites the system controller is “operatively connected to” one or more sensors used to detect the presence of a specimen container located at a pick-up station in the first automated detection apparatus. The phrase “operatively connected” does not necessarily require the system controller to utilize or perform any step beyond being connected to the sensors. In fact, assuming that the phrase “operatively connected” means that data gathered by the presence of the containers is used by the system controller, the system controller does not perform any step which would use that data to determine anything, which is confusing and indefinite.
Claim 1 now recites “upon determination by the system controller that a first ratio of available cell count to capacity in the first automated detection apparatus is less than a second ratio of total available cell count to total capacity of the first automated detection apparatus and the one or more downstream automated detection apparatus, wherein the available cell count and capacity are determined at least in part by the loading ability and transfer status of the first automated detection apparatus, and wherein the total available cell count and total capacity are determined at least in part by the loading ability and transfer status of the first automated detection apparatus as well as the second loading ability and second transfer status of the downstream automated detection apparatus”. It is not clear from the claim how the system controller determines (i.e., calculates) the available cell count and capacity “at least in part by” the loading ability and transfer status of the first automated detection apparatus. It is not clear “which part of the loading ability and transfer status of the first and second detection apparatus” the system controller uses to determine (i.e., calculate) a first ratio and a second ratio.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,625,025. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method for load balancing specimen containers between a plurality of automated detection apparatuses, said method comprising: receiving a specimen container at a container pick-up station in a first automated detection apparatus; and balancing the specimen containers across said first automated detection apparatus and a downstream automated detection apparatus by loading the specimen container into the first automated detection apparatus upon determination that the first apparatus is less full than an average of plurality of automated detection apparatuses and transferring the specimen container from the first automated detection apparatus to the downstream automated detection apparatus upon determination that the first automated detection apparatus is fuller than the average apparatus (determining cell availability in the first automated detection apparatus and in the downstream automated detection apparatus; transferring the specimen container from the first automated detection apparatus to said downstream automated detection apparatus upon determination that a first ratio of available cell count to capacity in the first automated detection apparatus is less than a second ratio of total available cell count to total capacity of the first automated detection apparatus and the downstream automated detection apparatus, wherein the available cell count and capacity are determined at least in part by the loading ability and transfer status of the first automated detection apparatus). The claim sets differ in that the patented method is limited to additional elements (e.g., overriding the transfer to the downstream automated detection apparatus upon determination that the cell availability in the first automated detection apparatus is determined to be within 5% of the total capacity of the first automated detection apparatus.) However, the open claim language “comprising” of the instant claims encompasses the additional elements of the patent. The scope of the instant claims are encompassed by those of the patented claims.
Response to Arguments
Applicant's arguments filed January 13, 2026 have been fully considered but they are not persuasive. With respect to the 35 USC 101, applicant argues that the method claims have been amended to include sensors, transfer mechanisms, holding structures, and detection units are which are not well understood, routine or conventional in the art and produce a concrete and real-world result. Applicant argues that physical movement of the container from a pickup station into an available cell within an automated detection apparatus is now in direct response to the loading availability, transfer status, cell availability determinations made by the system controller.
The examiner respectfully disagrees. As discussed above, the Bishop reference makes clear that container detection sensors, transfer mechanism, holding structure and detections units are well known, routine and conventional within the analyzer unit. The new container detector sensors have not been linked to any determination steps made by the system controller. The container detector sensors are only claimed as located at the container pickup station in the first automated detection apparatus. The claims are unclear how the system controller uses that container detection data at the pick up station in the first automated detection apparatus to determine the loading ability, transfer status, cell availability in the at least more downstream detection apparatuses and then calculate any ratios. The claims remain abstract and indefinite for the reasons delineated above.
Claims 1-7 are not being evaluated with respect to the prior art. MPEP 2173.06(II) states, “where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 102/103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. This is the case the claims are so unclear that making a prior art determination with respect to the instant claims is not possible.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on 9:30am-7:30 pm EST.
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E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798