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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/06/2026 has been entered.
Status of Claims
This action is in response to the RCE filed 01/06/2026.
Claims 1-6, 10-13, 18 were amended 01/06/2026.
Claims 1-20 are currently pending and have been examined.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “the one or more ASICs configured to send the control instructions to direct the physical pharmacy-fulfilment device to hold a prescription container, release the prescription container for downstream dispensing, or reroute the prescription container to a different location, by controlling a robotic arm or pick and place mechanism and conveyors to physically transform the prescription container in accordance with the record-matching result to prevent over-dispensing or under-dispensing of medication” in claim1 .
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 10, 13 and therefore their dependent claims are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 4, 10, and 13 recite the claim limitation of “the one or more ASICs are further configured to exclude the [second/third/patient] records identified as not matching from output used for clinical decision-making and to withhold transmission of the [second/third/patient] records identified as not matching” is not in the specification. The specification paragraph 124 recites that information not associated with the patient is not sent to the device. However, the exclusion of information not associated with the patient is communicated from a manager device that provides details to the interface (paragraphs 99, 117, 124) and is not implemented by one or more ASICs.
Claim Rejections - 35 USC § 112(b)
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, 10, 13, 18 and therefore their dependent claims 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 has the limitation “the one or more ASICs configured to send the control instructions to direct the physical pharmacy-fulfilment device to hold a prescription container, release the prescription container for downstream dispensing, or reroute the prescription container to a different location, by controlling a robotic arm or pick and place mechanism and conveyors to physically transform the prescription container in accordance with the record-matching result to prevent over-dispensing or under-dispensing of medication” in claim 1 has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it is unclear how it is possible how to physically transform the prescription container. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claims 1, 4, 10, and 13 recite the claim limitation of “the one or more ASICs are further configured to exclude the [second/third/patient] records identified as not matching from output used for clinical decision-making and to withhold transmission of the [second/third/patient] records identified as not matching” is not in the specification. The specification paragraph 124 recites that information not associated with the patient is not sent to the device. However, the exclusion of information not associated with the patient is communicated from a manager device that provides details to the interface (paragraphs 99, 117, 124) and is not implemented by one or more ASICs. It is unclear if the one or more ASICs is automatically excluding data in a different function. Clarification is required
Claim 13 recites “output a linkage record identifier for use in downstream transactions in place of the demographic information”, however it is unclear how the linkage record is in place of the demographic information as the specification paragraph 172 recites that the demographic information is re-organized without changing the demographic information and is silent on using a linkage record identifier. Clarification is required.
Claim 18 recites the limitation “outputting by the one or more ASICs, a linkage record identifier for use in subsequent processing of the patient records in place of demographic information”, however it is unclear how the linkage record is in place of the demographic information as the specification paragraph 172 recites that the demographic information is re-organized without changing the demographic information and is silent on using a linkage record identifier. Clarification is required.
Response to Arguments
The arguments filed 01/06/2026 have been fully considered.
The arguments pertaining to the claim objections are persuasive. The claims have been sufficiently amended and the objections have been withdrawn.
The arguments pertaining to the 112(a) rejections are partially persuasive. The arguments recite paragraph 124 to give support for the limitation of excluded records not used for clinical decision-making. The specification paragraph 124 recites that information not associated with the patient is not sent to the device. However, the exclusion of information not associated with the patient is communicated from a manager device that provides details to the interface (paragraphs 99, 117, 124) and is not implemented by one or more ASICs. Due to the amendments of the claim limitations positively reciting that the exclusion is made by the ASIC, a written description issue persists.
The arguments pertaining to the 112(b) rejections are partially persuasive. The rejection on claim 1 regarding the 112(f) issue persists as it is unclear how controlling a robot arm or pick and place mechanism and conveyors can physically transform a prescription container. A new 112(b) rejection has been made in regards to the amendments to 1, 4, 10, 3, and 18.
The arguments pertaining to the 101 rejection are persuasive. Specifically the claim limitation in independent claims 1, 4, 10, 13 and 18 of “release the prescription container for downstream dispensing, or reroute the prescription container to a different location, by controlling a robotic arm or pick and place mechanism and conveyors” in combination with the other claim limitations of the independent claims provide a practical application of specific improvement to technology. The 101 rejection has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Boyer (US 8060248 B1) teaches using a robotic arm to fill prescriptions but is not controlled by an ASIC that processes patient record matching data.
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/KIMBERLY A. SASS/Examiner, Art Unit 3686
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