NON-FINAL REJECTION
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 .
Examiner Interview
An examiner interview was held on 10/30/2025. During the interview, the examiner agreed to withdraw the restriction requirement and examine all pending claims (see Interview Summary PTO-413 form dated 10/31/2025).
Election/Restrictions
The restriction requirement articulated in the Office action dated 10/23/2025 is withdrawn in its entirety. Therefore, all pending claims (claim 1-20) are being examined.
In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Provisional Application No. 63/467,837 (filed 5/19/2023), fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for one or more claims of this application.
For example, claim 1 includes fluorescence detection and ultrasound but the prior-filed application makes no mention of fluorescence detection or ultrasound.
As another example, claim 9 includes images such as partial superimposed and images with ultrasound displayed separately but simultaneously, but the prior-filed application makes no mention of images, let alone partially superimposed and images with ultrasound displayed separately but simultaneously.
As another example, claim 16 includes displaying intensity of immunofluorescent green and more generally displaying intensity as counts and as an image, but the prior-filed application makes no mention of intensity, let alone of immunofluorescence green or more generally as counts and as an image.
Since the prior-filed application does not adequately disclose the claimed inventions, the prior-filed application cannot be relied upon for an earlier filing date. The effective filing date of the claimed inventions is therefore deemed to be the actual filing date of the non-provisional application (i.e., 5/19/2024).
Specification
The use of the term Magseed®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 9 is objected to because of the following informalities. Appropriate correction is required.
In claim 9, “IFG” should be spelled out as --immunofluorescence green (IFG)-- the first time it is recited in the claims.
In claim 13, “I.125” should be corrected to read as --I-125--.
In claim 17, “I.125” should be corrected to read as --I-125--.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 1: The claim recites a probe system comprising a handheld multimodality probe. The probe is narratively recited in the claim as one “that: receives installation of an RFID detection component embedded in a solid-state photomultiplier and scintillator unit of the probe, receives installation of a fluorescence detection component at an end area of the probe, and receives installation of ultrasound, Magseed®, and white light camera functionality”.
It is not clear to the ordinarily skilled artisan what this limitation is intended to cover. It is unclear whether this narrative should be interpreted as describing the intended use or functionality of the probe (i.e., that the probe is capable of receiving such components) or otherwise meant to describe how the probe is assembled (i.e., in the manner of a product-by-process limitation). In other words, it is unclear to what extent the claim covers the aforementioned components/functionalities installed in the probe, if at all.
To the extent that claim 1 recites the term “Magseed®” see the following discussion: The MPEP 2173.05(u) recites:
The presence of a trademark or trade name in a claim is not, per se, improper under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, but the claim should be carefully analyzed to determine how the mark or name is used in the claim. It is important to recognize that a trademark or trade name is used to identify a source of goods, and is not the name of the goods themselves. Thus a trademark or trade name does not define or describe the goods associated with the trademark or trade name. See definitions of trademark and trade name in MPEP § 608.01(v).
If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). See also Eli Lilly & Co. v. Apotex, Inc., 837 Fed. Appx. 780, 784-85, 2020 USPQ2d 11531 (Fed. Cir. 2020) ("Following Patent Office procedure, the Examiner in this case rejected the claims of the '821 application as indefinite because they improperly used the trade name 'ALIMTA.' In response to the rejection, Lilly canceled its claims reciting the trade name and pursued claims using the generic name for the same substance, which mooted the rejection. Additionally, as the district court observed, the Examiner 'explicitly noted that pemetrexed disodium was 'also known by the trade name ALIMTA' ' in the contemporaneous obviousness rejection."). The claim scope is uncertain since the trademark or trade name cannot be used properly to describe any particular material or product. In fact, the value of a trademark would be lost to the extent that it became the generic name of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name. If the applicant responds to such a rejection by replacing the trademark or trade name with a generic term, the examiner should determine whether there is sufficient support in the application for use of a generic term. See MPEP § 2163, subsection II.A.3(b).
If a trademark or trade name appears in a claim and is not intended as a limitation in the claim, the question of why it is in the claim should be addressed. If its presence in the claim causes confusion as to the scope of the claim, then the claim should be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In this case, the term Magseed® as recited in the claim appears to refer to a product or use thereof1. As discussed in the MPEP, if the trademark is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b).
In accordance with compact prosecution practice (see MPEP 2173.06), the claim is being interpreted for purposes of examination as requiring the aforementioned components/functionalities as part of the claimed probe; further, the term Magseed® is being construed as a magnetic surgical marker.
Dependent claims thereof (i.e., claims 2-8) are rejected for at least the same reasons as claim 1 because they inherit the deficiencies of claim 1 by virtue of their dependence thereof.
Regarding claim 2: Claim 2 also recite the trademark Magseed®. The discussion above similarly applies here.
The claim recites “wherein the probe providing access to six modalities comprising Tc99, I.125 modality, RFID, fluorescence, ultrasound and Magseed® enables a physician in an operating room to alternate between modalities without a need to change physical devices”.
Under the principles of claim differentiation, a dependent claim is assumed to have a different claim scope than the claim it depends on2. Applied to claim 2, this means that claim 2 is presumed to have a different claim scope than claim 1. The limitation of claim 2 appears to be a truism in the sense that a probe having those six modalities would inherently allow a physician to alternate between modalities without a need to change physical devices by virtue of being multimodality. However, the six modalities are already mentioned in claim 1. Claim 2 therefore seemingly violates the principle of claim differentiation which causes confusion as to the manner in which claim 2 was intended to further limit claim 1. Otherwise, if claim 2 indeed does not further limit claim 1, it is unclear as to why claim 2 as currently presented was included in the first place.
In accordance with compact prosecution practice (see MPEP 2173.06), the claim is being interpreted for purposes of examination as not being further limiting of claim 1 since claim 1 is being construed as already requiring the aforementioned modalities.
Regarding claim 3: The claim narratively recites that “the probe is connected to a control unit…”. It is unclear whether this narrative should be interpreted as describing the intended use or functionality of the probe (i.e., that is capable of being connected to a control unit) or otherwise meant to structurally limit the system and the probe (e.g., that the system further comprises a control unit connected to the probe). In other words, it is unclear to what extent the claim covers the aforementioned control unit, if at all.
In accordance with compact prosecution practice (see MPEP 2173.06), the claim is being interpreted for purposes of examination as including the control unit within the scope of the claimed invention (i.e., the control unit is being given patentable weight).
Regarding claim 4: There is insufficient antecedent basis for the term “the control unit”. Use of the definite article “the” implies that the claim is referring to a previously recited control unit. However, neither claim 4 nor the claim which it depends on (i.e., claim 1) ever recites a control unit prior to the recitation of “the control unit”. It is therefore unclear what/which control unit the term “the control unit” in claim 4 refers to. It is noted that claim 3 appears to provide antecedent basis for the control unit, however claim 4 does not depend on claim 3.
Further, it is unclear to the ordinarily skilled artisan what is precisely meant by “intensity counts of radiofrequency methods for breast lesion and tumor detection”. In particular, it is unclear what “radio frequency method” means.
Regarding claim 5: There is insufficient antecedent basis for the term “the control unit”. Use of the definite article “the” implies that the claim is referring to a previously recited control unit. However, neither claim 5 nor the claim which it depends on (i.e., claim 1) ever recites a control unit prior to the recitation of “the control unit”. It is therefore unclear what/which control unit the term “the control unit” in claim 5 refers to. It is noted that claim 3 appears to provide antecedent basis for the control unit, however claim 5 does not depend on claim 3.
In accordance with compact prosecution practice (see MPEP 2173.06), claim 5 is being interpreted for purposes of examination as depending on claim 3.
Regarding claim 6: There is insufficient antecedent basis for the terms “the control unit” and “the circuit board”. Use of the definite article “the” implies that the claim is referring to a previously recited control unit and a previously recited circuit board. However, neither claim 6 nor the claim which it depends on (i.e., claim 1) ever recites a control unit or circuit board prior to the recitation of “the control unit” and “the circuit board”. It is therefore unclear what/which control unit and circuit board the terms “the control unit” and “the circuit board” in claim 6 refer to. It is noted that claim 3 appears to provide antecedent basis for the control unit and claim 5 appears to provide antecedent basis for the circuit board, however claim 6 does not depend on claim 3, let alone claim 5.
In accordance with compact prosecution practice (see MPEP 2173.06), claim 6 is being interpreted for purposes of examination as depending on claim 5; and also claim 5 is being interpreted for purpose of examination as depending on claim 3 as already discussed above.
Regarding claim 9: It is unclear what is meant by “wherein the probe and control unit include IFG display as image, Tc-99 intensity displayed as image, include white light camera, include images wherein the images are at least partially superimposed, and further include images with ultrasound displayed separately but simultaneously” because limitation appear to further limit the probe and control unit by stating what it includes (i.e., a constituent structural parts), in particular the aforementioned images; however, images in this context are not constituent structural parts of a probe or control unit, rather they are information or data.
In accordance with compact prosecution practice (see MPEP 2173.06), the limitation in question is being construed as describing the kinds of images that the invention as a whole (i.e., the probe and control unit) are configured to display.
Regarding claim 11: Claim 11 also recite the trademark Magseed®. The discussion above similarly applies here.
Regarding claim 15: It is unclear to the ordinarily skilled artisan what is precisely meant by “intensity counts of radiofrequency method for at least one lesion where RFID disposable is inserted into the patient”. In particular, it is not clear what “radiofrequency method” means, let alone intensity counts thereof.
Regarding claim 16: The preamble of claim 16 recites a “method”, however the body of the claim reads more like a product (machine/apparatus, etc.). A method/process is comprised of steps and a product is comprised of structural elements. However, the claim as presented recites that the method is comprised of one or more structural elements (e.g., control unit and computer). This similarly applies to claims 17, 18, and 20
Further regarding claim 16, there is insufficient antecedent basis for the term “the computer”. It is unclear whether this refers to the control unit or another element.
In accordance with compact prosecution practice (see MPEP 2173.06), for purposes of examination this is being construed as referring to the control unit computer.
Further regarding claim 16, there is insufficient antecedent basis for the term “the device” in line 7 of the claim because it is unclear which “device” (the “probe device” or the “display device”) this refers to.
In accordance with compact prosecution practice (see MPEP 2173.06), for purposes of examination this is being construed as referring to the display device.
Regarding claim 17: Claim 17 also recite the trademark Magseed®. The discussion above similarly applies here.
Regarding claim 19: The claim appears to make reference of a displayed intensity count associated with Tc-99 technology, but it is unclear how this actually further limits the method. For example, the claim neither recites an additional step as part of the method nor further limits a step already recited as part of the method.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1 and dependent claims thereof: The prior art of record does not teach or reasonably suggest to the ordinarily skilled artisan a detection multimodality probe system for use in an operating room environment, comprising:
a handheld multimodality probe for at least lesion detection providing Tc99 and I-125 modalities that:
receives installation of an RFID detection component embedded in a solid-state photomultiplier and scintillator unit of the probe,
receives installation of a fluorescence detection component at an end area of the probe, and
receives installation of ultrasound, Magseed, and white light camera functionality.
Butani et al., US 2025/0191586 A1 (hereinafter “Butani”) is cited as prior art closest to the claimed invention. Butani discloses a detection multimodality probe system for use in an operating room environment, comprising a handheld multimodality probe (1114, Fig. 11) for at least lesion detection providing Tc99 and I-125 modalities (see ¶ [0052], [0113]-[0115]). Furthermore, Butani discloses additional modalities including RFID, fluorescence, ultrasound, magnetic seed/marker detection, and white light camera (¶ [0007], [0010], [0057], [0067], [0113]). However, Butani does not disclose that the RFID detection component is embedded in a solid-state photomultiplier and scintillator unit of the probe.
Regarding claim 9 and dependent claims thereof: Within the context of a multimodality probe and control unit, comprising:
a handheld multimodality probe for use in a surgical environment;
a control unit supporting the probe; and
a customization application executing on the unit that:
receives a first message from the probe in an operating room, the first message containing data describing tissue observed by the probe,
wherein the probe and control unit include IFG display as image, Tc-99 intensity displayed as image, include white light camera, include images wherein the images are at least partially superimposed, and further include images with ultrasound displayed separately but simultaneously,
the prior art of record does not teach or reasonably suggest to the ordinarily skilled artisan that the customization application:
receives a second message indicating at least one of a switching of modalities,
based at least on the received second message, changes an order of panels on a display screen in the operating room, each panel associated with a modality and displaying at least data generated by the modality
In addition to Butani already discussed above, the examiner also cites
Baumgartner et al., US 2014/0303486 A1 (hereinafter “Baumgartner”). Although Baumgartner teaches various modalities associated with different imaging volumes (e.g., see Fig. 8, left most column in Table1), arranging them as different “layers” in 3D space (see Fig. 4), and switching between them (e.g., turning on layers/groups on and off, ¶ [0068], [0086], [0135]), Baumgartner does not teach displaying the modalities as “panels” and changing the order that the panels as displayed on a display screen based on a user indication of switching of modalities.
Paladini, US 2013/0172739 A1 (hereinafter “Paladini”) teaches a probe and control unit configured to display images with ultrasound displayed separately but simultaneously (“Alternatively, the radiation reconstruction is displayed as a separate image, but adjacent to the ultrasound image.” ¶ [0133]). Although these images can be thought of as panels of different modalities, Paladini does not teach changing the order of these panels based on a user indication to switch modalities.
Regarding claim 16 and dependent claims thereof: Within the context of a method for displaying electronic content collected by a probe device in a surgical environment, comprising:
a control unit computer receiving data from a handheld multimodality probe in an operating room;
the computer, based on receiving a first instruction, activating a display device in the operating room;
the computer, based on receiving a second instruction, directing the device to display intensity of immunofluorescence green;
the prior art of record does not teach or reasonably suggest to the ordinarily skilled artisan:
the computer, based on receiving a third instruction, displaying the intensity (i.e., the intensity of immunofluorescence green) as counts; an
the computer, based on receiving a fourth instruction, discontinuing displaying the intensity as counts and commencing displaying the intensity as at least one image.
In addition to Butani, Baumgartner and Palidini, the examiner further cites Ganapati et al., US 2018/0210188 A1 (hereinafter “Ganapati”). Although Ganapati teaches displaying immunofluorescence green as an image, which includes determining quantitative intensity values of pixel thereof, Ganapati does not teach displaying this value as “counts” on a display (i.e., a numerical value on the display).
Additional prior art references are cited but are not any more relevant than those already cited above:
Yarnall et al., US 12,228,689 B2
Farsoni et al., US 2024/0164732 A1
Valdes et al., US 2023/0280577 A1
Yeom et al., US 2021/0186465 A1
Butani et al., US 11,039,803 B1
Caballero Ontanaya et al., US 2020/0100741 A1
Valdes et al., US 2019/0384048 A1
Subramanian et al., US 2018/0303445 A1
Wendler et al., US 2015/0305700 A1
The following claims are drafted by the examiner and considered to be allowable, are presented to applicant for consideration:
A detection multimodality probe system for using in an operating room environment comprising:
a handheld multimodality probe configured for the following modalities: detection of gamma emission from Tc99 and I-125, RFID detection, fluorescence detection, ultrasound imaging, magnetic surgical marker/seed detection, and white light imaging,
wherein the handheld multimodality probe comprises:
a solid-state photomultiplier and scintillator unit configured to detect gamma emission from Tc99 and I-125 for lesion detection,
an RFID detection component embedded in the solid-state photomultiplier and scintillator unit,
a fluorescence detection component at an end area of the handheld multimodality probe,
an ultrasound transducer configured for ultrasound imaging,
a magnetic surgical marker/seed detection unit, and
a camera configured for white light imaging.
(canceled)
The system of claim 1, further comprising a control unit connected to the handheld multimodality probe, wherein the control unit is configured to display, on a screen in the operating room, results of the probe’s operations in a layout according to user preference settings.
(canceled)
The system of claim 3, wherein the control unit is configured with operating modes respectively corresponding the Tc99 detection, the I-125 detection, the fluorescence detection component, the ultrasound transducer, the magnetic surgical marker/seed detection unit, and the camera,
wherein the control unit is further configured to:
receive a user selection of an operating mode, and
communicate the user selection to the handheld multimodality probe via Bluetooth
wherein the handheld multimodality probe further comprises a circuit board configured to:
control the Tc99 detection, the I-125 detection, the fluorescence detection component, the ultrasound transducer, the magnetic surgical marker/seed detection unit, and the camera in accordance with the respective operating modes, and
alternate between the operating modes based on the user selection
The system of claim 3, wherein RFID detection component is connected to the control unit via the circuit board
The system of claim, wherein hardware associated with each respectively modality including the solid-state photomultiplier and scintillator unit, the RFID detection component, the fluorescence detection component, the ultrasound transducer, the magnetic surgical marker/seed detection unit, and the camera is removable without affecting the other modalities, and
wherein software associated with each respective modality is removable without affecting the other modalities.
The system of claim 1, wherein the fluorescence detection component is installed in a front of the handheld multimodality probe without tungsten shielding and wherein the front of the handheld multimodality probe comprises a transparent front window configured to collect light for the fluorescence detection without interfering with the gamma emission detection.
The system of claim 1, further comprising:
a control unit configured, via a customization application executed thereon, to:
receive a first message from the handheld multimodality probe in the operating room, the first message containing data describing tissue observed by the handheld multimodality probe,
receive a second message indicating switching of modalities, and
based at least on the received second message, change an order of panels on a display screen in the operating room, wherein each panel is associated with a respective modality,
wherein the control unit is configured to display:
an immunofluorescence green (IFG) image,
a Tc99 intensity image,
a white light image, and
an ultrasound image,
wherein the control unit is configured to display images that are at least partially superimposed, and
wherein the control unit is configured to display the ultrasound image separately but simultaneously.
The system of claim 9, wherein the control unit is configured to change the order of the panels based on a direction of a physician using the probe.
(canceled)
The system of claim 9, wherein the control unit is configured to display the panels such that the panels include an array of count intensities measured by the handheld multimodality probe depending on user choice.
The system of claim 12, wherein a default intensity display, in the case where a user does not make a choice, is Tc99 and I-125 intensity for tumor detection and removal, and sentinel biopsies.
The system of claim 9, wherein the control unit is configured to display a selectable object entitled “I-125 SEED” which, when selected, causes the control unit to display intensity counts of a radioactive seed and distance from the seed in millimeters.
(canceled)
A method performed by the system of claim 1, wherein the system further comprises a control unit including a computer, wherein the method comprises performing, by the computer, the following steps:
receiving data from the handheld multimodality probe in the operating room;
receiving a first instruction;
activating a display device in the operation room based on the received first instruction;
receiving a second instruction;
displaying intensity of immunofluorescence green on the display device based on the received second instruction;
receiving a third instruction;
displaying the intensity of immunofluorescence green as counts on the display device based on the received third instruction;
receiving a fourth instruction;
discontinuing display of the counts and commencing display of the intensity of immunofluorescence green as an image based on the received fourth instruction.
The method of claim 16, further comprising observing, via the handheld multimodality probe, tissue using one modality selected from the group of modalities consisting of: the detection of gamma emission from Tc99 and I-125, the RFID detection, the fluorescence detection, the ultrasound imaging, and the magnetic surgical marker/seed detection.
The method of claim 16, further comprising directing, via the computer, the display device to transition to displaying a different interface on the display device, wherein the different interface includes more details of a displayed intensity count.
The method of claim 18, further comprising displaying an intensity count associated with detection of gamma emission from Tc99 and comprises at least one of background count subtract and sound zero level and energy setup form for radioactive tracers.
The method of claim 16, further comprising:
confirming, via the computer, display order preferences of a clinician for the order of the modalities and displaying data associated therewith and
transitioning to a screen displaying the data in the confirmed order.
Invitation for Examiner Interview
The examiner is available to discuss the merits of the case including options for moving forward. The examiner may be reached at the phone number listed below.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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, KEITH M. RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
17 April 2026
1 The name of the product appears to be “Magseed®” which is sold on the market by Endomagnetics Ltd (Endomag®) which has been acquired by Hologic, Inc. (Hologic®).
2 Kraft Foods, Inc. v. International Trading Company and Houston Processing Ltd., 203 F.3d 1362, 53 U.S.P.Q. 2d (BNA) 1814 (Fed. Cir. 2000), citing Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 48 USPQ2d 1001 (Fed. Cir. 1998) and Tandon Corp. v. U.S. Int’l Trade Comm’n, 831 F.2d 1017, 4 USPQ2d 1283 (Fed. Cir. 1987).