DETAILED ACTION
Status of Claims
This action is in reply to the application filed on March 24, 2025.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are currently pending and have been examined.
Double Patenting
This 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claims 1-19 of Patent #12451243.
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 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 broadest reasonable interpretation 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, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a computing device configured to” in claim 1, “a device details interface configured to” in claims 6 and 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without “significantly more.”
Regarding Claims 1 and 11, the claims recite medical devices inventory management using UDI which is a mental process (observation/evaluation) and a method of organizing a human activity (commercial/legal interaction-agreement). Tracking medical devices using UDI system is a global standard designed to uniquely identify medical devices from manufacturing through distribution to patient use improving safety, traceability and regulatory oversight. The limitations on receive UDI information, log the information, prepare a list of medical devices and transmit the list could be all performed in the human mind and/or with the help of paper and pencil. Other than reciting a scanner, a processor and a computing device nothing in the claim precludes the steps for being performed in the human mind and/or the help of paper and pencil. This judicial exception is not integrated into a practical application. The computers are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Generic computer components performing generic computer functions alone, do not amount to significantly more that an abstract idea. Simply implementing the abstract idea on a generic computer environment is not a practical application of the abstract idea and does not take the claim out of the mental process and method of organizing a human activity grouping. Moreover, when viewed as a whole with such additional elements considered as an ordered combination, the claim modified by adding a generic computer would be nothing more than a purely conventional computerized implementation of applicant's inventory management in the general field of supply chain and would not provide significantly more than the judicial exception itself. The claims are directed to an abstract idea.
The claims do not include additional elements that even in combination are sufficient to amount to significantly more than the judicial exception. As discussed above, with respect to integration of the abstract idea into a practical application, the additional element of using computers to perform the receiving, logging, preparing and transmitting steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. There are no improvements to technology or any new technology involved. The claims are not patent eligible.
Regarding dependent claims 2-10 and 12-20, these claims are directed to limitations which serve to limit the components, the processing steps and the information used. These claims neither introduce a new abstract idea nor additional limitations which are significantly more than an abstract idea. They provide descriptive details that offer helpful context, but have no impact on statutory subject matter eligibility.
Therefore the limitations on the invention, when viewed individually and in ordered combination are directed to in-eligible subject matter.
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)(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) 1-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Debusk (WO 2018/093706A1).
Claim 1
Debusk discloses the following limitations:
A computer-implemented system, the system comprising: at least one scanner configured to scan a barcode provided on each of a plurality of medical devices for a first plurality of medical device information associated with each of the plurality of medical devices, (see at least abstract, paragraphs 0004-0006-scanning a UDI and paragraph 0020).
the at least one scanner integrated within a computing device configured to receive the first plurality of medical device information from the at least one scanner for each medical device of the plurality of medical devices, wherein the first plurality of medical device information comprises at least a unique device identifier (UDI) for each medical device of the plurality of medical devices; (see at least paragraph 0014-data collection interface).
and a processor in operable communication with the computing device, the processor adapted to: log the first plurality of medical device information for each medical device of the plurality of medical devices; (see at least abstract-the manufacturer registers the UDI for each medical item in a tracking database).
prepare a list of the plurality of medical devices, wherein the list includes the first plurality of medical device information associated with each of the plurality of medical devices; (see at least abstract-the manufacturer registers the UDI for each medical item in a tracking database).
and transmit the list to an external computing device. (see at least paragraph 0020-the UDI tracking database complements the FDA database).
Claim 2
Furthermore, Debusk disclose the following limitations:
wherein the processor is further adapted to:
interpret the UDI for each medical device of the plurality of medical devices; and
automatically pull from a database a second plurality of medical device information associated with each medical device of the plurality of medical devices based on the interpreted UDI, wherein the second plurality of medical device information comprises at least one of a model number, a device name, and a device description. (see at least abstract, paragraphs 0006 and 0020).
Claim 3
Furthermore, Debusk disclose the following limitations:
wherein the second plurality of medical device information further comprises a manufacturer, a package quantity, a package type, and/or recall information. (see at least paragraphs 0006, 0017 and 0020).
Claim 4
Furthermore, Debusk disclose the following limitations:
wherein the processor is further adapted to:
aggregate the first and second pluralities of medical device information; and
log the aggregated first and second pluralities of device information to a system database. (see at least paragraphs 0006 and 0020).
Claim 5
Furthermore, Debusk disclose the following limitations:
wherein the processor is further adapted to display a visual rendering of the aggregated first and second pluralities of medical device information that is viewable on a graphical user interface. (see at least paragraphs 0006, 0017 and 0020).
Claim 6
Furthermore, Debusk disclose the following limitations:
wherein the graphical user interface comprises a device details interface configured to receive manually inputted medical device information. (see at least paragraph 0097).
Claim 7
Furthermore, Debusk disclose the following limitations:
wherein the list includes the aggregated first and second pluralities of medical device information. (see at least paragraphs 0006, 0017 and 0020).
Claim 8
Furthermore, Debusk disclose the following limitations:
wherein the first plurality of medical device information further comprises an expiration date, a lot number, a serial number, and a date of manufacture. (see at least paragraphs 0006 and 0020).
Claim 9
Furthermore, Debusk disclose the following limitations:
wherein the processor is further adapted to generate an alert to a user if the medical device being scanned is within 90 days of the expiration date or if the medical device being scanned has an FDA recall. (see at least paragraph 0043).
Claim 10
Furthermore, Debusk disclose the following limitations:
wherein the alert is a visual indicator displayed on an interface. (see at least paragraph 0043 and 0068).
As per claims 11-20, claims 11-20 recite substantially similar limitations to claims 1-10 and are therefore rejected using the same art and rationale set forth above.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENISSE Y ORTIZ ROMAN whose telephone number is (571)270-5506. The examiner can normally be reached Monday-Thursday 9-7.
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/DENISSE Y ORTIZ ROMAN/Examiner, Art Unit 3627
/FAHD A OBEID/Supervisory Patent Examiner, Art Unit 3627
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