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 .
Election/Restrictions
Applicant's election with traverse of Group I, drawn to a probe-guide apparatus for guiding, identifying, and harvesting a biopsy sample, in the reply filed on 10/13/25 is acknowledged.
The traversal is on the ground(s) that the groups of identified inventions share the same special technical feature of the probe-guide apparatus thereby unifying a single concept because Van Der Zagg does not demonstrate the shared features, lacking (i) a design to host exchangeable devices to be exchanged during surgery and instead the device must be withdrawn to for correct biopsy needle arrangement, (ii) the optical fibers are not arranged in close proximity to the tip, and (iii) the side-looking biopsy device must be removed necessitating several in and out insertions such that it is not suitable to be used during surgery .
This is not found persuasive because the alleged distinctive inventive elements are (i) not recited in the identified groups such that they even could be a shared feature(s) and thus cannot be a special technical feature, (ii) the claims do recite a “a design to host exchangeable devices”, “exchangeable devices”, and/or “a single surgical insertion”, (iii) Van Der Zaggs optical fibers may reasonably be considered “in close proximity to the tip” as broadly as claimed, and (iv) it remains that the shared feature(s) do not comprise a special technical feature unifying the inventions under a single inventive concept due to the demonstrated evidence of Van Der Zagg (see pages 3-5 mailed 8/13/25).
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/13/25.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
The use of the term FL400, FL500, Medtronic, , 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, at least the “four optical fibers”, “the energy source”, “the removable biopsy needle”, “the probe and the biopsy needle are not arranged in the lumen of the probe-guide simultaneously”, “the light spectrometer later”, “the LDF laser”, “the Ramer laser”, “the spectrometer detector”, “the laser doppler detector”, “the Ramen detector”, “the pointer”, and “transmitting signals from a device” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim Objections
Claim 1 is objected to because of the following informalities: the recitations of “iii)” and “iv)” do not appeared ordered to start at (i) and would seem to be instead “i)” and “ii)”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: there appears to be for extra recitations of “and”. Appropriate correction is required.
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 and 11 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.
For claim 1, the term “substantially tube-shaped” in claim 1 line 2 is a relative term which renders the claim indefinite. The term “substantially tube-shaped” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claimed invention is indeterminate with respect to what degree of tube-like shape is required and/or what degree of un-tube-like shape is excluded to be considered “substantially tube-shaped” for the probe-guide. Depending claims 2-7 and 11 inherit and do not remedy the indefiniteness.
For claim 1, the term “preferably” in claim 1 is a relative term which renders the claim indefinite. The term “preferably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claimed invention is indeterminate with respect to the second opening arrangement at a distance from the distal end or tip and if the sidewall of the probe guide arrangement is necessarily required for the claimed invention, particularly given the optional or conditionality of the term “preferably”. ”. Depending claims 2-7 and 11 inherit and do not remedy the indefiniteness.
Regarding claim 1 line 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Depending claims 2-7 and 11 inherit and do not remedy the indefiniteness.
For claim 1, the term “essentially tube-shaped” in claim 1 line 10 is a relative term which renders the claim indefinite. The term “essentially tube-shaped” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claimed invention is indeterminate with respect to what degree of tube-like shape is required and/or what degree of un-tube-like shape is excluded to be considered “essentially tube-shaped” for the prove. Depending claims 2-7 and 11 inherit and do not remedy the indefiniteness.
Claim 2 recites “the width (diameter) is in the range of 1.5-3 mm”. Claim 2 recites limitations in parentheses that are not reference numerals. The scope of claim 2 is indefinite because it is indeterminate if the “(diameter)” is explicitly, implicitly, inherently, and/or necessarily required.
Regarding claims 3-5:
Claim 3 recites “The probe-guide comprising the probe according to claim 1…”.
Claim 4 recites “The probe-guide comprising the probe according to claim 1…”.
Claim 5 recites “The probe-guide and probe according to claim 1…”.
Claims 3-5 are indefinite because it is indeterminate if (a) the claims are intended to be independent, (b) the claims selectively contain or omit the other, non-recited elements contained in claim 1, and/or (c) the claims are intended to be dependent from claim 1 containing all of the recited claim limitations therefrom. The scope of the claims is unclear and ambiguous given that the preamble appears to infer that elements from claim 1 are not included and that the claims may be independent while merely referring to claim 1 for completeness. One of ordinary skill in the art would not be apprised of the metes and bounds of the scope of the claimed invention in light of the instant Specification given the uncertainty.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-7 and 11 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 lines 2-3 positively recites “the probe-guide… is for insertion into a body”.
Claim 1 lines 9-11 positively recites “the probe… is for insertion into a body”.
The scope of claim 1 explicitly, implicitly, inherently, and/or necessarily requires a portion of a human organism, particularly including a human body. Thus, claim 1 is non-statutory as encompassing a portion of a human organism. Depending claims 2-7 and 11 inherit and do not remedy the non-statutory nature.
In an effort to promote compact prosecution, the Examiner respectfully notes Applicant may have intended to positively recite “the probe-guide… is configured for insertion into a body”, ”the probe-guide… is adapted for insertion into a body”, or the like, which would obviate the non-statutory nature.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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) 1-7 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hibner et al. (US 2011/0201965 A1, hereinafter Hibner).
For claim 1, Hibner discloses a probe-guide (38) for guiding, identifying, and harvesting a biopsy (Figs 2,3,8-13,19) ([0049-0087]), the probe-guide is substantially tube-shaped (Figs 2,3,8-13,19) ([0049-0053]), having a distal and a proximal end wherein the distal end is for insertion into a MRI bore body (Figs 2,3,8-13,19) ([0049-0053]) and the proximal end is for connection to an energy source (18) (Fig 1), wherein the wall of the probe-guide comprises a first (central opening) (Figs 2,3,8-13,19) ([0049-0053]) and a second (exterior openings) (Figs 2,3,8-13,19) ([0049-0053]) opening, the first opening is arranged in the distal end or tip (Figs 2,3,8-13,19) ([0049-0053]), the second opening is arranged at a distance from the distal end or tip in the sidewall of the probe-guide (Figs 2,3,8-13,19) ([0049-0053]), and wherein the probe-guide is designed to receive another device into its lumen (Figs 2,3,8-13,19) ([0049-0053]) such as:
iii) a removable optical probe ([0083]) for optical guidance and/or identification of malign tissue, wherein the probe is essentially tube-shaped outer housing accommodating optical fibers ([0083]), the probe has a distal and a proximal end wherein the distal end is for insertion into a body and the proximal end is for connection to an energy source ([0083]), optical fiber pairs are arranged in close proximity towards the distal end (Figs 2,3,8-13,19), the optical fibers at least 4 and the diameter of the fibers are in the range of 125 to 250 micron ([0083]), the probe is removably arranged into the lumen of the probe-guide (250) (Fig 19) ([0083)]) configured to transmit and receive light via the first opening, and/or
iv) a removable biopsy needle (58) (Fig 4) ([0053]) for harvesting a biopsy, wherein the biopsy needle is removably arranged into the lumen of the probe-guide (Fig 4, 19) ([0083]) and configured to harvest a biopsy via the second opening (second openings assist in biopsy via securement),
wherein the probe and the biopsy needle are not arranged in the lumen of the probe-guide simultaneously (Fig 19) ([0083]).
For claim 2, Hibner discloses the probe-guide according to claim 1, wherein the length a of the probe-guide is in the range of 100-300 mm, and the width is in the range of 1.5-3 mm (based on the 1cm biopsy needle accommodation) (Fig 4) ([0014]).
For claim 3, Hibner discloses the probe-guide according to claim 1, wherein the length of the probe is in the range of 50-400 mm ([0083] and based on the 1cm biopsy needle accommodation) (Fig 4) ([0014]).
For claim 4, Hibner discloses the probe-guide according to claim 1, wherein the probe comprises a light spectrometer laser; a LDF laser; a Raman laser; a spectrometer detector; a laser doppler detector; and a Raman detector ([0083]).
For claim 5, Hibner discloses the probe-guide according to claim 1, wherein the material of the probe-guide and probe is medical steel ([0053]).
For claim 6, Hibner discloses the probe-guide according to claim 1, wherein a pointer (arrow marking Fig 8) for electromagnetic navigation is arranged into the lumen of the probe-guide (Figs 2,3,8-13,19) ([0049-0053]).
For claim 7, Hibner discloses the probe-guide according to claim 1, wherein a device ([0083]) for delivering a medicament ([0083]) is arranged into the lumen of the probe-guide.
For claim 11, Hibner discloses the probe-guide according to claim 1, comprising openings for transmitting signals from a device (radiation therapy device of [0083]) arranged or inserted into the lumen of the probe-guide, for removal of tissue by vaporization, abrasion, or destruction (radiation therapy device of [0083]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring a probe guide for biopsy acquisition.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791