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 !, drawn to the tissue separation apparatus, in the reply filed on 9/30/25 is acknowledged. The traversal is on the ground(s) that now amended claim 21 of Group 2 includes common elements, including an elongate body, a tissue separator, and a pressure-applying device, such that unity of invention is now present as this is not disclosed by Namati. The traversal appears silent regarding the relationship(s) amongst Group 3 with respect to Groups 1 and 2.
This is not found persuasive because the amended claimed invention lacks unity of invention, wherein the different categories of invention are not so linked to form a single general inventive concept. It remains that Namati demonstrates it is well known, routine and conventional to configure a medical device with an elongate body (100), a tissue separator (112), and a pressure-applying device (114). Thus, unity of invention remains lacking because the shared technical features are not a special technical feature unifying the inventions with a single inventive concept and a defined contribution over the art, particularly as broadly as claimed.
The requirement is still deemed proper and is therefore made FINAL.
Claims 21-23, 25, 27, and 29-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 9/30/25.
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 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 at least:
“pressure-applying device” in claim 1,
“release mechanism” in claim 2, and
“projecting member” in claim 13.
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 § 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) 1-5, 7-10 and 12-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams et al. (US 2018/0360495 A1, hereinafter Adams).
For claim 1, Adams discloses a tissue separation device (1900), comprising inter alia:
an elongate body (1900) (Figs 19A-19I) ([0172-0190, 0197-0205]) comprising: a proximal end portion (left end portion Fig 19A); and a distal end portion (right end portion Fig 19A);
a tissue separator (1915) (Figs 19A-19I) ([0172-0190, 0197-0205])coupled to the distal end portion, the tissue separator configured to engage sample tissue for retrieval (Figs 19A-19I) ([0172-0190, 0197-0205]); and
a pressure-applying device (suction on position of multi-stage trigger 1912) (Figs 19A-19I) ([0172-0190, 0197-0205], especially [0178]) coupled to not only one but both of the elongate body and the tissue separator and that is configured to bias the tissue separator against the sample tissue (Figs 19A-19I) ([0172-0190, 0197-0205]).
For claim 2, Adams discloses the tissue separation device of claim 1, further comprising a release mechanism (suction-off position of multi-stage trigger 1912) ([0178]) to selectively activate the pressure-applying device from the proximal end portion of the elongate body (Figs 19A-19I) ([0172-0190, 0197-0205]).
For claim 3, Adams discloses the tissue separation device of claim 2, further comprising a container (1920) (Fig 19B) ([0172-0190, 197-0205]) to receive tissue retrieved by the tissue separator (Figs 19A-19I) ([0172-0190, 0197-0205]).
For claim 4, Adams discloses the tissue separation device of claim 3, wherein the tissue separator comprises a scraping device (1915) (Figs 19A-19I) ([0172-0190, 0197-0205]).
For claim 5, Adams discloses the tissue separation device of claim 4, wherein the scraping device comprises a blade (1915), wherein: the container comprises an opening (lumen into 1920 Fig 19B); and the blade is disposed along an edge of the opening (1915 is disposed on lumen into 1920) (Figs 19A-19I) ([0172-0190, 0197-0205]).
For claim 7, Adams discloses the tissue separation device of claim 5, wherein the blade is configured to cut tissue when the scraping device moves in a direction extending from the distal end portion toward the proximal end portion (Figs 19A-19I) ([0172-0190, 0197-0205]).
For claim 8, Adams discloses the tissue separation device of claim 3, wherein the tissue separator comprises a penetrating device (Figs 19A-19I) ([0172-0190, 0197-0205]).
For claim 9, Adams discloses the tissue separation device of claim 8, wherein the penetrating device comprises an auger (Figs 19A-19I, especially 19F) ([0172-0190, 0197-0205]).
For claim 10, Adams discloses the tissue separation device of claim 9, wherein: the container comprises an opening (lumen into 1920); and the auger wraps around the opening (1915 is disposed around opening into lumen for 1920) (Fig 19F); wherein the auger is configured to cut tissue when the tissue separator is rotated about a central axis (Figs 19A-19I) ([0172-0190, 0197-0205]).
For claim 12, Adams discloses the tissue separation device of claim 3, wherein the pressure-applying device comprises a biased actuator (Figs 19A-19I, especially 19C) ([0172-0190, 0197-0205]).
For claim 13, Adams discloses the tissue separation device of claim 12, wherein the biased actuator comprises: a projecting member connected to the container at a pivot point (Fig 19B); and a spring configured to bias the projecting member away from the container housing (Fig 18B).
For claim 14, Adams discloses the tissue separation device of claim 13, wherein the release mechanism comprises: a sleeve (1917) configured to slide along the elongate body between a distal position and a proximal position (Figs 19A-19I) ([0172-0190, 0197-0205]); and a pull-cord (1925) connected to the sleeve and configured to extend along the elongate body to the proximal end portion (Figs 19A-19I) ([0172-0190, 0197-0205]); wherein in the distal position the sleeve is configured to press the projecting member against the tissue separator collector (Figs 19A-19I) ([0172-0190, 0197-0205]); and wherein the pull-cord is configured to move the sleeve to the proximal position to allow the projecting member to pivot away from the tissue collector (Figs 19A-19I) ([0172-0190, 0197-0205]).
For claim 15, Adams discloses the tissue separation device of claim 3, wherein the pressure-applying device comprises an expandable body (1912 in conjunction with scope 300, Fig 23) (Figs 19A-19I, 23) ([0172-0190, 0197-0205]).
For claim 16, Adams discloses the tissue separation device of claim 15, wherein the expandable body comprise an inflatable bladder (distension step) (Figs 19A-19I, 23) ([0172-0190, 0197-0205]).
For claim 17, Adams discloses the tissue separation device of claim 16, wherein the release mechanism comprises: a valve (1950) connected to the inflatable bladder (Figs 19A-19I, 23) ([0172-0190, 0197-0205]); and a fluid tube extending from the valve (1951).
For claim 18, Adams discloses the tissue separation device of claim 3, further comprising a shield (1914) configured to selectively cover the tissue separator (Figs 19A-19I, 23) ([0172-0190, 0197-0205]).
For claim 19, Adams discloses the tissue separation device of claim 3, wherein the container is resiliently flexible (Figs 19A-19I, especially Fig 19B) ([0172-0190, 0197-0205]).
For claim 20, Adams discloses the tissue separation device of claim 1, further comprising: an endoscope (300) comprising a first longitudinal passage (Fig 4, 23); and an auxiliary scope (303) comprising a second longitudinal passage (Fig 3, 23), where the auxiliary scope is configured to slide in the first longitudinal passage (Figs 3-4, 23); wherein the tissue separation device (1900) is configured to slide in the second longitudinal passage (Figs 3-4, 23).
Claim(s) 1-4, 8, 12, 15, 16, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kapelowitz (US 3,680,558), especially as broadly as structurally and/or functionally claimed.
For claim 1, Kapelowitz discloses a tissue separation device, comprising inter alia:
an elongate body (12) comprising: a proximal end portion (left end portion Fig 1); and a distal end portion (right end portion Fig 1);
a tissue separator (14) coupled to the distal end portion (Fig 1), the tissue separator configured to engage sample tissue for retrieval (needle samples blood which is tissue); and
a pressure-applying device (40) coupled to both of the elongate body and the tissue separator and that is configured to bias the tissue separator against the sample tissue .
For claim 2, Kapelowitz discloses the tissue separation device of claim 1, further comprising a release mechanism (42) to selectively activate the pressure-applying device from the proximal end portion of the elongate body.
For claim 3, Kapelowitz discloses the tissue separation device of claim 2, further comprising a container (44) to receive tissue retrieved by the tissue separator.
For claim 4, Kapelowitz discloses the tissue separation device of claim 3, wherein the tissue separator comprises a scraping device (14).
For claim 8, Kapelowitz discloses the tissue separation device of claim 3, wherein the tissue separator comprises a penetrating device (abstract).
For claim 12, Kapelowitz discloses the tissue separation device of claim 3, wherein the pressure-applying device comprises a biased actuator (40 is manually biased).
For claim 15, Kapelowitz discloses the tissue separation device of claim 3, wherein the pressure-applying device comprises an expandable body (Fig 4).
For claim 16, Kapelowitz discloses the tissue separation device of claim 15, wherein the expandable body comprise an inflatable bladder (22 inflates with sampled tissue).
For claim 19, Kapelowitz discloses the tissue separation device of claim 3, wherein the container is resiliently flexible (container 40 inherently has a resilient flexibility).
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 device for bodily tissue sampling.
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