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 without traverse of Group II, drawn to the bone biopsy assembly of claims 10-13 and 30, in the reply filed on 7/17/26 is acknowledged.
Claims 17, 25-29, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/17/26.
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.
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 lost motion receiver” in claim 30; and
“a drive connector” in claim 30.
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.
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 10-13 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 10 positively recites “…the trephine needle is being seated in the bone prior to boring”. The scope of the claimed invention necessarily requires the at least a portion of the human body when the trephine needle is seated “in the bone”, rendering the scope of the claim non-statutory subject matter for requiring the human body. For the purposes of compact prosecution, the Examiner respectfully recommends reciting “…the trephine needle is configured to be seated in a bone prior to boring”, or the like, which would appear to obviate the issue. Depending claims 11-13 inherit and do not remedy the non-statutory issue.
Claim 13 positively recites “…whereby one is able to visually monitor a depth of the bone biopsy during bone boring”. The scope of the claimed invention necessarily requires the at least a portion of the human body when the trephine needle is seated “in the bone”, rendering the scope of the claim non-statutory subject matter for requiring the human body. For the purposes of compact prosecution, the Examiner respectfully recommends reciting “…wherein the indicia are configured to provide visual monitoring of a depth of a bone biopsy procedure (or assembly) during bone boring”, or the like, which would appear to obviate the issue.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 positively recites the limitation "the bone" in line 3. There is insufficient antecedent basis for this limitation in the claim. Consistent with the instant Specification and as appears to be the intent, the Examiner respectfully recommends alternatively reciting “a bone”, or the like. Depending claims 11-13 inherit and do not remedy the indefiniteness.
Claim 13 positively recites the limitation “the bone biopsy” in line 3. There is insufficient antecedent basis for this limitation in the claim. Consistent with the instant Specification and as appears to be the intent, the Examiner respectfully recommends alternatively reciting “a bone biopsy”, or the like.
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) 10-13 and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peliks et al. (US 2021/0275154 A1, hereinafter Peliks).
For claim 30, Peliks discloses a bone biopsy assembly (100) (Fig 2) ([0027-0063]), comprising inter alia:
a lost motion receiver (110) having a proximal end and a distal end (Fig 2) ([0027-0063]);
a trephine needle (150) including an elongated shaft having a first end, a second end and a lumen extending from the first end to the second end (Fig 2) ([0027-0063]);
a stylet (160) received for sliding movement within the lumen and the lost motion receiver wherein the stylet includes an elongated body having a pointed tip (161) at a first terminus and a head (162) at a second terminus (Fig 2,7A,7B) ([0027-0063]);
a drive connector (117) at the proximal end of the lost motion receiver and a cutting edge (151) at the first end of the trephine needle (Fig 2) ([0027-0063]);
a coupler (158) releasably securing the lost motion receiver to the trephine needle wherein the coupler includes (a) a male connector (159) at the second end of the trephine needle, (b) a cooperating female connector (142) at the distal end of the lost motion receiver, (c) a locking ring (112) carried on the lost motion receiver and (d) a cooperating locking boss (128) carried on the trephine needle (Fig 2) ([0027-0063]); and
a stylet seat (117, 154) at the second end of the trephine needle adapted for receiving and holding said head of said stylet when the stylet is positioned within the trephine needle in a trephine needle seating position with the pointed tip projecting beyond the cutting edge wherein the stylet seat is provided in the male connector and the stylet seat is in the form of an acircular socket (154) and the head includes an acircular cross section (cross section of hub 154 includes protruding lugs 155) whereby when the stylet is in the trephine needle seating position, the head is received in the acircular socket and the stylet is locked for rotation with the trephine needle (Fig 2) ([0027-0063]).
For claim 10, Peliks discloses the bone biopsy assembly of claim 30, further including a removable stop (124) that is engaged in an opening in the lost motion receiver to secure the stylet in the trephine needle seating position when the trephine needle is being seated in the bone prior to boring (Fig 2) ([0027-0063]).
For claim 11, Peliks discloses the bone biopsy assembly of claim 10, wherein the lost motion receiver includes an outer wall (outside of 111) outlining a lost motion chamber adapted to accommodate sliding movement of the stylet during bone boring with the bone biopsy assembly (Fig 2) ([0027-0063]).
For claim 12, Peliks discloses the bone biopsy assembly of claim 11, further including at least one window (111 as polyethylene, known to be transparent) in the outer wall allowing one to view the stylet as it slides in the lost motion chamber of the lost motion receiver (Fig 2) ([0027-0063]).
For claim 13, Peliks discloses the bone biopsy assembly of claim 12, further including indicia (114) on (a) the trephine needle, (b) the lost motion receiver or (c) the trephine needle and the lost motion receiver whereby one is able to visually monitor a depth of the bone biopsy during bone boring (Fig 2) ([0027-0063]).
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 bone biopsy retrieving device.
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.
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, 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
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