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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 21-35) in the reply filed on 06/05/2026 is acknowledged. A supplemental election of species b.ii. (Fig. 11), c.iv. (Fig. 12), and d.ix. (Fig. 15) was made in an interview on 07/30/2026.
Claims 36-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 21-35 are currently under consideration.
Information Disclosure Statement
Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 21, 30, and 31 are objected to because of the following informalities:
Regarding claims 21 and 31, the recitations of “the tissue sample holder is in” should instead read –the tissue sample holder in--.
Regarding claim 30, the recitation of “claim 21, the sample” should instead read –claim 21, wherein the sample--.
Appropriate correction is required.
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: “control module” in claim 21.
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 § 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.
Claim 27 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 27, the recitation of “further configured to one or more calcifications” is unclear because of an apparent missing word. For purposes of examination, it will be interpreted as configured to detect.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-26, 28, 29, and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2014/0039343 (“Mescher”) in view of US Patent Application Publication 2014/0163414 (“Lee”).
Regarding claim 21, Mescher teaches [a] biopsy system (Abstract, Fig. 1, system 2), comprising: (a) a biopsy device (Fig. 1, device 10), wherein the biopsy device includes: (i) a body (Fig. 1, probe 100 and holster 200), (ii) a needle (Fig. 1, needle 110), (iii) a cutter, the needle extending from the body to collect tissue samples using the cutter (Fig. 5, cutter 150, ¶ 0095), … and (v) a tissue sample holder, …, the tissue sample holder being configured to receive tissue samples … (Figs. 9-11, tissue sample holder 300, ¶ 0106); and (b) a control module, wherein the control module is in communication with the biopsy device (¶ 0121, Fig. 22B, a microcontroller – also see Fig. 1, control module 400).
Mescher does not appear to explicitly teach (iv) a sample analyzer including a gate and a detector, the gate being configured to selectively arrest movement of a tissue sample within the sample analyzer for analysis using the detector, wherein the tissue sample holder is in communication with the sample analyzer, the tissue sample holder being configured to receive tissue samples after analysis by the sample analyzer (although the tissue sample holder does store samples at the end of travel).
Lee teaches a biopsy device that incorporates a gate and detector as a sample analyzer (Figs. 6a and 6b, valve V and electrical signal inspector 410 in relation to storage 290 – also see ¶¶s 0026, 0027, 0120, etc.), the gate being configured to selectively arrest movement of a tissue sample within the analyzer for analysis (¶ 0147), the analyzer being in communication with a tissue sample holder (storage 290 itself and/or the end of the pneumatic line as shown in Fig. 4b and described in ¶ 0124) for storage after analysis (¶ 0113).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sample analyzer of Lee into Mescher, including before or with the tissue sample holder, for the purpose of being able to evaluate characteristics of the sample (Lee: ¶¶s 0027, 0082, 0120, etc.).
Regarding claim 22, Mescher-Lee teaches all the features with respect to claim 21, as outlined above. Mescher-Lee further teaches the gate being configured to transition between an open and closed position to selectively arrest a tissue sample before transport to the tissue sample holder (Lee: ¶ 0147, opening necessary to receive the flow, and closing necessary to prevent reverse-flow).
Regarding claim 23, Mescher-Lee teaches all the features with respect to claim 21, as outlined above. Mescher-Lee further teaches the analyzer further including a sample lumen (Lee: Fig. 6a, receiving the sample into storage 290), the detector being in communication with the control module (Mescher: ¶ 0121, it would have been obvious to use the microcontroller to control this aspect of the device as well), the detector protruding into the sample lumen (Lee: Fig. 6a, physical contact necessary for use of the electrodes – also see Lee: ¶ 0019, obvious to use different heights for the purpose of interrogating different sized samples), the sample lumen being in communication with the cutter to receive a tissue sample therein (receiving a sample as in Lee: Fig. 6a).
Regarding claims 24 and 25, Mescher-Lee teaches all the features with respect to claim 23, as outlined above. Mescher-Lee further teaches the detector including a pair of bioimpedance electrodes, a portion of each bioimpedance electrode extending into the sample lumen to physically contact a tissue sample received in the sample lumen, the pair of bioimpedance electrodes being in communication with the control module, the control module being configured to measure an impedance associated with the tissue sample using the pair of bioimpedance electrodes (Lee: Fig. 6a, showing a pair – also see ¶ 0120, describing impedance).
Regarding claim 26, Mescher-Lee teaches all the features with respect to claim 24, as outlined above. Mescher-Lee further teaches the pair of bioimpedance electrodes being in communication with the control module, the control module being configured to generate a measured impedance associated with the tissue sample using the pair of bioimpedance electrodes, the control module being further configured to identify one or more properties of the tissue sample using the measured impedance (Lee: ¶¶s 0008, 0082, 0097, etc., characteristics of the tissue based on impedance).
Regarding claim 28, Mescher-Lee teaches all the features with respect to claim 24, as outlined above. Mescher-Lee further teaches a portion of each bioimpedance electrode of the pair of bioimpedance electrodes being exposed to an exterior of the sample analyzer (Lee: Fig. 6a, the conductive portions leading to signal transmitter 411 and signal receiver 412).
Regarding claim 29, Mescher-Lee teaches all the features with respect to claim 24, as outlined above. Mescher-Lee further teaches a portion of each bioimpedance electrode of the pair of bioimpedance electrodes being exposed to an exterior of the sample analyzer to define a communication portion of each bioimpedance electrode, the communication portion of each bioimpedance electrode being configured to engage a portion of the body to communicate electrical current with the body (Lee: Fig. 6a, the conductive portions leading to signal transmitter 411 and signal receiver 412).
Regarding claim 31, Mescher teaches [a] biopsy device (Fig. 1, device 10), comprising: (a) a body (Fig. 1, probe 100 and holster 200), (b) a needle (Fig. 1, needle 110), (c) a cutter, the needle extending from the body to collect tissue samples using the cutter (Fig. 5, cutter 150, ¶ 0095), … and (e) a tissue sample holder, …, the tissue sample holder being configured to receive tissue samples … (Figs. 9-11, tissue sample holder 300, ¶ 0106).
Mescher does not appear to explicitly teach (d) a sample analyzer including a gate and one or more electrodes, the gate being configured to selectively arrest movement of a tissue sample within the sample analyzer for analysis using the one or more electrodes, wherein the tissue sample holder is in communication with the sample analyzer, the tissue sample holder being configured to receive tissue samples after analysis by the sample analyzer (although the tissue sample holder does store samples at the end of travel).
Lee teaches a biopsy device that incorporates a gate and one or more electrodes as a sample analyzer (Figs. 6a and 6b, valve V and electrical signal inspector 410 in relation to storage 290 – also see ¶¶s 0026, 0027, 0097 (electrodes for determining characteristics such as impedance), 0120, etc.), the gate being configured to selectively arrest movement of a tissue sample within the analyzer for analysis (¶ 0147), the analyzer being in communication with a tissue sample holder (storage 290 itself and/or the end of the pneumatic line as shown in Fig. 4b and described in ¶ 0124) for storage after analysis (¶ 0113).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sample analyzer of Lee into Mescher, including before or with the tissue sample holder, for the purpose of being able to evaluate characteristics of the sample (Lee: ¶¶s 0027, 0082, 0120, etc.).
Regarding claim 32, Mescher-Lee teaches all the features with respect to claim 31, as outlined above. Mescher-Lee further teaches the sample analyzer being integrated into a portion of the tissue sample holder (Lee: as shown in Fig. 6a).
Regarding claim 33, Mescher-Lee teaches all the features with respect to claim 31, as outlined above. Mescher-Lee further teaches a portion of the sample analyzer defining a cutter passage configured to slidably receive a portion of the cutter, the one or more electrodes being in communication with the cutter passage (Lee: as shown in Fig. 6a, the lumen defining a cutter passage that interfaces with the cutter 150 of Mescher (Fig. 5, ¶ 0095)).
Regarding claim 34, Mescher-Lee teaches all the features with respect to claim 31, as outlined above. Mescher-Lee further teaches a portion of the sample analyzer defining a cutter passage configured to slidably receive a portion of the cutter, the one or more electrodes including a pair of electrodes, the pair of electrodes extending parallel relative to each other through a portion of the cutter passage (Lee: as shown in Fig. 6a, the lumen defining a cutter passage that interfaces with the cutter 150 of Mescher (Fig. 5, ¶ 0095); Lee: Fig. 6a also shows a pair of parallel electrodes).
Regarding claim 35, Mescher-Lee teaches all the features with respect to claim 31, as outlined above. Mescher-Lee further teaches the cutter, the sample analyzer, and the tissue sample holder being aligned along a common axis (Mescher: Fig. 5; Lee: Fig. 6a).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Mescher-Lee in view of US Patent Application Publication 2014/0180273 (“Nair”).
Regarding claim 27, Mescher-Lee teaches all the features with respect to claim 24, as outlined above. Mescher-Lee further teaches the pair of bioimpedance electrodes being in communication with the control module (as above), the control module being configured to generate a measured impedance associated with the tissue sample using the pair of bioimpedance electrodes (as above), but does not appear to explicitly teach the control module being further configured to one or more calcifications disposed within the tissue sample using the measured impedance.
Nair teaches that impedance properties can distinguish different types of plaques, including calcified plaques (¶¶s 0127, 0200).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the detected impedance to determine calcification, as in Nair, for the purpose of being able to detect and distinguish plaques (Nair: ¶ 0127).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Mescher-Lee in view of US Patent Application Publication 2011/0208087 (“Trezza II”).
Regarding claim 30, Mescher-Lee teaches all the features with respect to claim 21, as outlined above. Mescher-Lee does not appear to explicitly teach the sample analyzer includes a tissue window, the tissue window being disposed within the body of the biopsy device and being sealed relative to an exterior of the biopsy device
Trezza II teaches making portions of probe 200 and transport tube 226 transparent, or incorporating windows therein (¶ 0051).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a tissue window into the sample analyzer of the combination, as in Trezza II, for the purpose of enabling a user to confirm sample capture and transport (Trezza II: ¶ 0051).
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 21-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 10,905,404 in view of Mescher, Lee, Nair, and/or Trezza II. Claim 1 teaches all features except for those made up by Mescher, Lee, Nair, and/or Trezza II as outlined above.
Claims 21-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 11,998,179 in view of Mescher, Lee, Nair, and/or Trezza II. Claim 1 teaches all features except for those made up by Mescher, Lee, Nair, and/or Trezza II as outlined above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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