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 .
Specification
The disclosure is objected to because of the following informalities: the applications listed in paragraph [000236] of the specification require updating with respect to patent numbers.
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 2-7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 2, term “the primary structure” lacks antecedent basis. It appears that this should be “the proximal structure”.
Dependent claims inherit those defects.
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 one drive mechanism” in claim 1;
“angled feature” in claim 5;
“articulation feature” in claim 6;
“first drive mechanism” and “second drive mechanism” in claim 7;
“mechanical grounding member” in claims 11, 16, and 20;
“deflection feature” in claim 19.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 2019/0388163, hereinafter “Kim”).
As to claim 1, Kim discloses an apparatus, comprising:
(a) a scope base (base portion 80, Fig.4) configured to be positioned extracorporeally relative to a patient (is capable of being placed outside of a patient), wherein the scope base is configured to attach to at least one drive mechanism (attached to drive mechanisms 60,70, Fig.4);
(b) an outer sheath (tube unit 10, Figs.1,4) extending distally from the scope base;
(c) an insertion channel (space through tube unit 10 and base portion 80 that accommodates the scope shaft, Fig.4) extending through each of the scope base and the outer sheath; and
(d) a scope shaft (20/30/40/67, Fig.3A) actuatable relative to the scope base and slidably disposed within the insertion channel ([0032],[0037], Fig.3A,3B), wherein the scope shaft includes:
(i) a rigid proximal shaft portion (tube body 40, Fig.3A) configured to be driven by the at least one drive mechanism ([0059]),
(ii) a deflectable distal shaft portion (steering unit 20, Fig.3A), wherein the deflectable distal shaft portion is deflectable relative to the proximal shaft portion ([0051], Figs.2A,2B), and
(iii) a distal end configured to provide visualization of a body cavity (35, Fig.2A, can accommodate an image sensor, [0038]).
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.
Claim(s) 2-4, 11, and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2019/0388163, hereinafter “Kim”) in view of Poulsen et al. (US 2023/0301504, hereinafter “Poulsen”).
At to claim 2, Kim, as set forth above with respect to claim 1, fails to disclose a cannula, wherein the cannula includes:(i) a proximal structure configured to be positioned extracorporeally relative to a patient, and (ii) a distal structure extending distally from the proximal structure and configured to be passed through a body wall and into a body cavity of the patient, wherein the distal structure cooperates with the primary structure to define a primary axis and a working channel sized and configured to receive and guide the deflectable distal shaft portion distally therethrough along the primary axis. Poulsen teaches, in a similar scope apparatus (see Figs.7-14), to provide a cannula (base 2, insertion tube 81,Figs.8,12,20) including a proximal structure (base 2) configured to be positioned extracorporeally relative to a patient (base 2 attached to outer skin, [0097]), and (ii) a distal structure (tube 81) extending distally from the proximal structure and configured to be passed through a body wall and into a body cavity of the patient (insertion through body opening, [0099]), wherein the distal structure cooperates with the primary structure to define a primary axis and a working channel sized and configured to receive and guide the deflectable distal shaft portion distally therethrough along the primary axis (connector passage within base/tube receives scope tube 4, Fig.9, [0099]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the scope device of Kim with a cannula, as taught by Poulsen, in order to aid in insertion of the scope device of Kim through the patients skin (Poulsen: [0012]) as well as for sealing the opening through the skin in which the scope device is inserted (Poulsen:[0008]).
As to claim 3, wherein the outer sheath is releasably coupled to the cannula (as modified by Poulsen, the cannula is designed to be releasably coupled to the outer sheath, see Fig.12 of Poulsen for example, showing cannula 81 decoupled from the outer sheath 4 (which is analogous to Kim’s outer sheath 10)).
As to claim 4, wherein the outer sheath is integrally formed with the cannula (as modified by Poulsen, when coupled, e.g. Fig.8 of Poulsen, the outer sheath 4 (analogous to Kim’s outer sheath 10) is integrally formed with the cannula 81).
As to claims 11 and 14-15, Kim discloses the apparatus of claim 1 (see rejection of claim 1 over Kim above), but fails to disclose a stabilizing patch (mechanical grounding member) configured to stabilize a distal portion of the outer sheath relative to a body wall of the patient via an adhesive applied to a bottom surface of the stabilizing patch for adhering the stabilizing patch to the body wall of the patient. Poulsen teaches that it is known in a similar scope apparatus (see Figs.7-14) to provide a stabilizing patch (base 2) with an adhesive layer (adhesive 80) at the proximal end of the scope device in order to facilitate easy and sealing attachment (stability) of the scope to the outer skin surface of a patient (Fig.7, [0097]) and allow hand free operation of the device [0006]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a stabilizing patch/adhesive with the Kim scope device for the reasons taught by Poulsen ([0006],[0097]).
As to claims 16 and 17, Kim discloses an apparatus, comprising:(a) a scope base configured to be positioned extracorporeally relative to a patient; (b) an outer sheath extending distally from the scope base; (c) an insertion channel extending through each of the scope base and the outer sheath; (d) and a scope shaft actuatable relative to the scope base and slidably disposed within the insertion channel, wherein the scope shaft includes a deflectable shaft portion (see rejection of claim 1 above with respect to Kim). Kim fails to disclose a mechanical grounding member configured to stabilize a distal portion of the outer sheath relative to a body wall of the patient, wherein the mechanical grounding member is operatively coupled to the outer sheath extracorporeally. Poulsen teaches that it is known in a similar scope apparatus (see Figs.7-14) to provide a mechanical grounding member/stabilizing patch (base 2) with an adhesive layer (adhesive 80) at the proximal end of the scope device in order to facilitate easy and sealing attachment (stability) of the scope to the outer skin surface of a patient (Fig.7, [0097]) and allow hand free operation of the device [0006]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a stabilizing patch/adhesive with the Kim scope device for the reasons taught by Poulsen ([0006],[0097]).
Claim(s) 5-6, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2019/0388163, hereinafter “Kim”) and Poulsen et al. (US 2023/0301504, hereinafter “Poulsen”) and further in view of Okada (US 2013/0197535).
As to claims 5 and 6, Kim in view of Poulsen, as set forth above with respect to claim 2, provides for a straight cannula and thus fails to disclose that the cannula further includes an angled feature/articulation feature at a distal end of the distal structure, wherein the angled feature is configured to direct/articulate relative to the proximal structure the deflectable distal shaft portion along a secondary axis that is angled relative to the primary axis. Okada teaches to provide a cannula with an angled/articulation feature (e.g. angled/articulated feature 3/50 between distal end side tube 4 and proximal end side tube 2, Figs.1,5,6) at the distal end of the distal structure for directing an inserted instrument, such as an endoscope ([0003]), at an angle from the primary axis of the cannula, as a beneficial alternative to a straight cannula (Fig.18A,18B). Okada teaches that this angled feature/articulation feature allow more accurate and correctly aligned placement of the inserted instrument (e.g. endoscope, [0003]) with the target site ([0103], note difference between Figs.18A,18B and Fig.1). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a cannula with a angled/articulation feature in the Kim/Poulsen apparatus for the predictable result of improving placement ease and accuracy of the inserted endoscope, as taught Okada.
As to claim 19, Kim discloses a system, comprising:
(a) a support structure (base 80, Fig.4);
(b) a motorized drive mechanism (drive mechanisms 60,70, Fig.4) coupled to the support structure;
(c) a surgical scope, including: (i) a scope base (not numbered by the structure holding proximal end of tube 10, Fig.4) coupled with the motorized drive mechanism (scope base is coupled between 10 and 60,70, Fig.4), and (ii) a scope shaft (20/30/40/67, Fig.3A) that is actuatable relative to the scope base by the motorized drive mechanism ([0032],[0037],Fig.3A,3B), wherein the scope shaft includes: (A) a rigid proximal shaft portion (tube body 40, Fig.3A) and (B) a deflectable distal shaft portion (steering unit 20, Fig.3A).
Kim fails to disclose a cannula, wherein the cannula includes:(i) a proximal structure configured to be positioned extracorporeally relative to a patient, and (ii) a distal structure extending distally from the proximal structure and configured to be passed through a body wall and into a body cavity of the patient, wherein the distal structure cooperates with the primary structure to define a primary axis and a working channel sized and configured to receive and guide the deflectable distal shaft portion distally therethrough along the primary axis. Poulsen teaches, in a similar scope apparatus (see Figs.7-14), to provide a cannula (base 2, insertion tube 81,Figs.8,12,20) including a proximal structure (base 2) configured to be positioned extracorporeally relative to a patient (base 2 attached to outer skin, [0097]), and (ii) a distal structure (tube 81) extending distally from the proximal structure and configured to be passed through a body wall and into a body cavity of the patient (insertion through body opening, [0099]), wherein the distal structure cooperates with the primary structure to define a primary axis and a working channel sized and configured to receive and guide the deflectable distal shaft portion distally therethrough along the primary axis (connector passage within base/tube receives scope tube 4, Fig.9, [0099]).
Kim in view of Poulsen, as set forth above, provides for a straight cannula and thus fails to disclose that the cannula further includes a deflection feature configured to direct the deflectable distal shaft portion along a secondary axis that is angled relative to the primary axis. Okada teaches to provide a cannula with a deflectable feature (e.g. feature 3/50 between distal end side tube 4 and proximal end side tube 2, Figs.1,5,6) at the distal end of the distal structure for directing an inserted instrument, such as an endoscope ([0003]), at an angle from the primary axis of the cannula, as a beneficial alternative to a straight cannula (Fig.18A,18B). Okada teaches that this deflectable feature allows more accurate and correctly aligned placement of the inserted instrument (e.g. endoscope, [0003]) with the target site ([0103], note difference between Figs.18A,18B and Fig.1). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a cannula with a deflectable feature in the Kim/Poulsen apparatus for the predictable result of improving placement ease and accuracy of the inserted endoscope, as taught Okada.
As to claim 20, Kim/Poulson, as set forth above, fails to disclose a mechanical grounding member configured to stabilize a distal portion of the outer sheath relative to a body wall of the patient, wherein the mechanical grounding member is operatively coupled to the outer sheath extracorporeally. Poulsen teaches that it is known in a similar scope apparatus (see Figs.7-14) to provide a mechanical grounding member/stabilizing patch (base 2) with an adhesive layer (adhesive 80) at the proximal end of the scope device in order to facilitate easy and sealing attachment (stability) of the scope to the outer skin surface of a patient (Fig.7, [0097]) and allow hand free operation of the device [0006]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a stabilizing patch/adhesive with the Kim scope device for the reasons taught by Poulsen ([0006],[0097]).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2019/0388163, hereinafter “Kim”) in view of Kimmel et al. (US 2007/0162095, hereinafter “Kimmel”).
As to claims 8-10, Kim, as set forth above with respect to claim 1, fails to disclose the particular characteristic of the outer sheath, specifically whether it is flexible, rigid, or both1 (i.e., selectively flexible and rigid, e.g. malleable/shape retaining). It has to be one of these. Where there is a limited universe of potential options, the selection of any particular option would have been obvious to one of ordinary skill in the art. In re Jones, 412 F.2d 241, 162 USPQ 224 (CCPA 1969). Furthermore, Kimmel teaches that an outer sheath of a conventional endoscope can comprise a malleable (shape-retaining) material to allow it to be selectively bent (in one, i.e. flexible, state) and retain such bend (in another, i.e. rigid, state). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the Kim outer sheath to either be flexible, rigid or selectively both (as taught by Kimmel) depending on the particular purpose or desired characteristics.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2019/0388163, hereinafter “Kim”) in view of Nakajima (U.S. Pat. 4,854,301).
Kim discloses the apparatus of claim 1 (see rejection of claim 1 over Kim above), but fails to disclose a stabilizing arm as a mechanical grounding member configured to stabilize a distal portion of the outer sheath relative to a body wall of the patient, wherein the stabilizing arm is configured to selectively transition between a flexible state and a rigid state. However, stabilizing arms for stabilizing an endoscope (which includes an outer sheath with a distal portion inserted into the body) are well know in the art (Nakajima: e.g. flexible/rigid arm 161, Fig.14, flexible/rigid arm 185, Fig.17), and particularly stabilizing arms that are selectively flexible and rigid (e.g. holding arm 191, Fig.21, in which electromagnetic clutches 193 are actuatable to allow the arm to flex or hold rigid, col.12, lines 48-66). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a stabilizing arm as known in the art and taught by at least Nakajima, in order to provide the predictable result of holding the endoscope sheath steady relative to a body cavity, which desirably aids in visualization and performing procedures and reducing fatigue on an operator (Nakajima: col.2, lines 30-35).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2019/0388163, hereinafter “Kim”) and Poulsen et al. (US 2023/0301504, hereinafter “Poulsen”), as set forth above with respect to claim 16, and further in view of Kimmel et al. (US 2007/0162095, hereinafter “Kimmel”).
As to claim 18, Kim, as set forth above with respect to claim 16, fails to disclose the particular characteristic of the outer sheath, specifically whether it is flexible, rigid, or both (i.e., selectively flexible and rigid, e.g. malleable/shape retaining). It has to be one of these. Where there is a limited universe of potential options, the selection of any particular option would have been obvious to one of ordinary skill in the art. In re Jones, 412 F.2d 241, 162 USPQ 224 (CCPA 1969). Furthermore, Kimmel teaches that an outer sheath of a conventional endoscope can comprise a malleable (shape-retaining) material to allow it to be selectively bent (in one , i.e. flexible state) and retain such bend (in another, i.e. rigid, state). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the Kim outer sheath to either be flexible, rigid or selectively both (as taught by Kimmel) depending on the particular purpose or desired characteristics.
Allowable Subject Matter
Claim 7 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited on PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P LEUBECKER whose telephone number is (571)272-4769. The examiner can normally be reached Generally, M-F, 5:30-2:00.
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, Anhtuan T Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN P LEUBECKER/Primary Examiner, Art Unit 3795
1 It is noted that the terms “flexible” and “rigid” are broad terms that can overlap in definition, wherein “rigid” element can still have some flexibility (unless 100% fully rigid by definition) and a “flexible” element can still have some rigidity (unless 100% fully flexible, if this is even possible). Almost all elements fall within the ends of this spectrum (i.e. some rigidity, some flexibility).
Prosecution Insights