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 .
Response to Amendment
The cancellation of claims 10-16, 19, 21, 24, 26, 31-32, addition of claims 34-44, and the amendments to claims 17-18, 22-23, 25, 27-30 and 33, in the response filed on 16 October, 2025 are acknowledged.
Claims 17-18, 22-23, 25, 27-30 and 33-44 remain pending in the application.
Claims 1-16, 19-21, 24, 26 and 31-32 are cancelled.
Claims 17-18, 22-23, 25, 27-30 and 33-44 are examined.
Response to Arguments
Rejection under 35 USC 112 (b).
Argument:
In regards to unnamed claims, the applicant argues that “feature” is not a nonce term and connotates structure, hence that limitations like “features to transfer roll torques”, “locking features… designed to provide stiffness in bending… to transfer pitch and yaw torques”, “mechanical features” and “surface features designed to assist the surgeon in rotating” should not be rejected under 112 (b) for lack of clarity about invoking 112 (f).
In particular, the applicant argues this is as “feature” is not a nonce term, that “feature” connotes structure, and that the Oh declaration argues “feature” connotes structure [in the applicant's arguments dated 16 October, 2026, page 20-23].
Response:
The examiner respectfully disagrees.
MPEP 2181 I reads, in part:
“Accordingly, examiners will apply 35 U.S.C. 112(f) to a claim limitation if it meets the following 3-prong analysis:
(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
...
In response to the Office action that finds that 35 U.S.C. 112(f) is invoked, if applicant does not want to have the claim limitation interpreted under 35 U.S.C. 112(f), applicant may: (1) present a sufficient showing to establish that the claim limitation recites sufficient structure to perform the claimed function so as to avoid interpretation under 35 U.S.C. 112(f);
or (2) amend the claim limitation in a way that avoids interpretation under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function).”
In this excerpt, “nonce” is clearly not being used in the fashion of applicant’s supplied definition and to fundamentally limit the generic placeholder. Generic placeholder terms do not stop being generic placeholders simply by being used frequently.
More importantly, the above-quoted standard for applicant’s rebuttal is “present a sufficient showing to establish that the claim limitation recites sufficient structure to perform the claimed function so as to avoid interpretation under 35 U.S.C. 112(f)” (see above MPEP quote), and not providing a showing that the limitation recites any structure to any degree. Applicant has not attempted to show that “feature” recites any specific structure.
As such, this argument is found to be unconvincing.
Argument:
In regards to unnamed claims, the applicant argues that “features… designed to” is modified by sufficient structure, as for all of these, physical structures comprise these “features…designed to” items.
Further, applicant argues that “peripheral force-transmittal surfaces” are part of the “locking features” hence provide sufficient structure for the locking features.
Hence that limitations like “features to transfer roll torques”, “locking features… designed to provide stiffness in bending… to transfer pitch and yaw torques”, “mechanical features” and “surface features designed to assist the surgeon in rotating” should not be rejected under 112 (b) for lack of clarity about invoking 112 (f).
[in the applicant's arguments dated 16 October, 2026, page 23].
Response:
The examiner respectfully disagrees.
The standard for applicant’s rebuttal is “present a sufficient showing to establish that the claim limitation recites sufficient structure to perform the claimed function so as to avoid interpretation under 35 U.S.C. 112(f)” [See MPEP 2281 I], and not simply provide a showing that the limitation recites any structure to any degree.
Further, the “peripheral force-transmittal surfaces” are explicitly part of another separate item in the claims, and not part of the “locking features”.
As such, this argument is found to be unconvincing.
Argument:
In regards to unnamed claims, the applicant argues that under the doctrine of claim differentiation, as independent claim 33 invokes 112 (f) unambiguously, other claims which use analogous limitations “features to transfer roll torques”, “locking features… designed to provide stiffness in bending… to transfer pitch and yaw torques”, “mechanical features” and “surface features designed to assist the surgeon in rotating” should not be rejected under 112 (b) for lack of clarity about invoking 112 (f).
[in the applicant's arguments dated 16 October, 2026, page 23].
Response:
The examiner respectfully disagrees.
The applicant has provided no citation regarding “the doctrine of claim differentiation” in this or the referenced argument of March 2025.
Hence, this argument is found to be unconvincing.
The applicant provides other arguments based on combinations of art (particularly Hu’045, Orbay’128, Ouyang’441, Krupa’896 all together) which have not been used again in this office action. These arguments are therefore moot.
The applicant provides other arguments that 37 C.F.R § 1.83 is invalid to the degree it exceeds its statutory authority, such that it should not be applied as it has in this case. This appears to be a question for judicial ruling.
Drawings
The drawings were received on 16 October, 2025. These drawings are unacceptable. Fig.7 is not entered because it contains new matter. While it is clear this was an attempt at not exceeding the initially disclosed subject matter, new detail (ie the relationship of the mounting to the imaging and illumination) is provided therein. It is noted that the claims of 16 October, 2026 are currently amended so as not to require a figure illustrating the mounting, imaging and illumination.
Information Disclosure Statement
The information disclosure statement filed 2 September, 2023 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner's initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
The transmittal letter of 2 September, 2023 indicates an accompanying form PTO-1449, however the examiner has not seen a separate PTO-1449 on the record for this entry.
This notice was previously provided in the office action of 2 September, 2024, and in the office action of 16 June, 2025, however no response has been received on this issue.
Claim Interpretation
In regards to claims 17 and 22, claim 17 reads “the separation joint designed…to reconnect a second insertion shaft at the separation joint…” [lines 32 and 35]. Here, the second insertion shaft is not positively recited. It is noted claim 17 has been amended from a process claim to a product claim, and the applicant may have intended to recite the second insertion shaft in another way.
Claim 22, depending from claim 17, also does not positively recite the second insertion shaft.
In regards to claim 28, the claim reads “the separation joint is designed to permit removal of a first insertion shaft for disposal and replacement, and to reconnect a second insertion shaft” [lines 3-4]. Here, the first and second insertion shafts are not positively recited.
In regards to claim 36, the claim reads “the separation joint designed to permit removal of a first insertion shaft…. and to reconnect a second insertion shaft…” [lines 2-4]. In this claim, the first and second insertion shafts are not positively recited.
Claim Objections
Claims 35-36 are objected to because of the following informalities:
In regards to claims 35-36, the claims do not provide indentation where new items are provided. Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). See MPEP 6.08.01 (m).
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.
The applicant’s amendments of 16 October, 2025 include extensive revisions of the claims. As a result, some of the 35 USC § 112 rejections of the previous action are withdrawn.
Claims 17-18, 22-23, 25, 27-30 and 33-44 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 pre-AIA the applicant regards as the invention.
In regards to claims 17, 27, 33-34 and 38, claim limitations features to transfer roll torques in claims 17, 27 and 34, locking features in claims 17, 27 and 34, mechanical features in claims 17, 27 and 33, surface features designed to assist the surgeon in rotating in claim 38, have been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, as the claim limitations use 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, but do not use the term "means", and the applicant has not requested interpretation of the terms under 112 (f) in previous rounds of prosecution. The boundaries of these claim limitations are ambiguous; therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant's intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
In regards to claim 17, the claim recites “a separation joint between the proximal handle portion and the first insertion shaft designed to separably connect the first insertion shaft to the proximal handle portion” [claim 17 lines 11-12], “the separation joint having facing flat force-transmittal surfaces....that, when the separation joint is connected and locked, abut” [claim 17 lines 20-21], “the separation joint designed…to reconnect a second insertion shaft at the separation joint…” [claim 17, lines 32 and 35].
Here, it is not clear if “the separation joint” mentioned in line 35 is the same as the separation joint recited earlier in the claim, as it is not clear if the separation joint has portions only attached to the proximal handle portion, making these different mentions of “the separation joint” the same, or if the separation joint has separate portions (here, specifically the abutting force-transmittal surfaces) respectively attached to the proximal handle portion and insertion shaft, whereby a second shaft attached to the proximal handle would form a different instance of “the separation joint”. As the latter is the applicant’s disclosed configuration, and the former is not, it will be assumed that the latter is the case.
In regards to claim 18, the claim reads “the insertion shaft” [lines 3-5]. Here, it is unclear if this is the same as the first insertion shaft of claim 17, the second insertion shaft of claim 17, or if this is a newly recited item. Therefore, the claim is unclear. For the purposes of prosecution, this will be assumed to be the same as the first insertion shaft of claim 17.
In regards to claim 23, the claim reads “the insertion shaft” [lines 2-3, 7]. Claim 33, from which claim 23 depends, reads “a plurality of insertion shafts” [line 2]. Here, the antecedent basis for “the insertion shaft” is unclear. Therefore the claim is unclear. For the purposes of prosecution, it will be assumed that “the insertion shaft” is one of the plurality of insertion shafts.
In regards to claim 28, the claim reads “the separation joint is designed… to reconnect a second insertion shaft at the separation joint” [lines 2-3], where claim 27 from which claim 28 depends reads “the separation joint having facing flat force-transmittal surfaces at or near a periphery of the separation joint that, when the separation joint is connected and locked, abut” [lines 19-20]. Here, it is not clear if “the separation joint” mentioned in claim 28 is the same as the separation joint recited in claim 27, as it is not clear if the separation joint has portions only attached to the proximal handle portion, making these different mentions of “the separation joint” the same, or if the separation joint has separate portions (here, specifically the abutting force-transmittal surfaces) respectively attached to the proximal handle portion and insertion shaft, whereby a second shaft attached to the proximal handle would form a different instance of “the separation joint”. As the latter is the applicant’s disclosed configuration, and the former is not, it will be assumed that the latter is the case.
In regards to claim 29, the claim reads “each of the insertion shafts connectable to the proximal handle portion at the separation joint” [lines 7-8] whereas claim 27 from which claim 29 depends reads “the separation joint having facing flat force-transmittal surfaces at or near a periphery of the separation joint that, when the separation joint is connected and locked, abut” [lines 19-20]. Here, it is not clear if “the separation joint” mentioned in claim 28 is the same as the separation joint recited in claim 27, as it is not clear if the separation joint has portions only attached to the proximal handle portion, making these different mentions of “the separation joint” the same, or if the separation joint has separate portions (here, specifically the abutting force-transmittal surfaces) respectively attached to the proximal handle portion and insertion shaft, whereby a second shaft attached to the proximal handle would form a different instance of “the separation joint”. As the latter is the applicant’s disclosed configuration, and the former is not, it will be assumed that the latter is the case.
In regards to claim 33, the claim reads “a separation joint at the distal end of the proximal handle portion designed to permit removal of a first one of the plurality of insertion shafts…and to reconnect a second one of the plurality of insertion shafts” [lines 15-17], “the separation joint having facing flat force-transmittal surfaces....that, when the separation joint is connected and locked, abut” [lines 26-28].
Here, it is not clear if “the separation joint” mentioned in line 15 is the same as the separation joint recited later in the claim, as it is not clear if the separation joint has portions only attached to the proximal handle portion, making these different mentions of “the separation joint” the same, or if the separation joint has separate portions (here, specifically the abutting force-transmittal surfaces) respectively attached to the proximal handle portion and insertion shaft, whereby a second one of the plurality of insertion shafts attached to the proximal handle would form a different instance of “the separation joint”. As the latter is the applicant’s disclosed configuration, and the former is not, it will be assumed that the latter is the case.
In regards to claim 33, the claim reads “a separation joint designed… to reconnect a second one of the plurality of insertion shafts separably connect a respective one of the insertion shafts to the proximal handle portion at the separation joint” [lines 15-19]. There appears to be language missing between “plurality of insertion shafts” and “separably connect”. The text after “plurality of insertion shafts” cannot be understood without undue speculation. Therefore, the claim is unclear.
In regards to claim 34, the claim reads “a handle” [line 2] and “a handle” [line 11]. It is unclear if these are meant to be the same item. Therefore, the claim is unclear. For the purposes of prosecution, it will be assumed these are the same item.
In regards to claim 34-35, the claims read “the proximal handle portion” [claim 34, line 13] and “the insertion shaft and proximal handle portion”, [claim 35 lines 4-5]. There is insufficient antecedent basis for the proximal handle portion limitation in the claims. Therefore, the claims are unclear. For the purposes of prosecution, it will be assumed that this is the same as the handle of line 2 of claim 34.
In regards to claims 34-35 and 37-39, the claims read “a plurality of endoscope insertion shafts” [claim 34, line 2] and “the endoscope insertion shaft” [claim 34, lines 14-17, 19, claim 35 lines 3-4, claim 37, lines 2-4, claim 38 lines 4-5, claim 39 line 2].
Here, the antecedent basis of “the endoscope insertion shaft” is unclear. Therefore, the claims are unclear. For the purposes of prosecution, it will be assumed that “the endoscope insertion shaft” is one of the plurality of endoscope insertion shafts.
In regards to claim 43, the claim reads “The endoscope of claim 34, further comprising:
two or more endoscope insertion shafts having, respectively, dimensions different than the others, each connectable to the handle at the separation joint, to permit use of the handle in surgery with different requirements for the endoscope insertion shaft.”
Here, it is unclear if, in conjunction with claim 34 requiring “a plurality of endoscope insertion shafts”, this limitation requires the endoscope to have four or more endoscope insertion shafts, ie. whether or not these are the same as the plurality of endoscope insertion shafts of claim 34. Therefore, the claim is unclear.
This new claim is supported by applicant’s paragraph original disclosure, paragraph 5, which reads in part “Two or more insertion shafts each having dimensions different than the others, may each be connectable to the proximal handle portion at the joint, to permit use of the proximal handle in surgery with different requirements for insertion shaft.”
As it is apparent that in the relevant disclosure the two shafts are not in addition to other shafts, and that this appears to be the applicant’s intended interpretation, the “two or more insertion shafts” of claim 43 are interpreted to be the same as “a plurality of endoscope insertion shafts” of claim 34.
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, d*escribed 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.
Claims 17-18 are rejected under 35 U.S.C. 102(b) as anticipated by Birkrant (US 2014/0107416).
In regards to claim 17, Birkrant discloses an endoscope, comprising a handle [102, portions of 104 proximal to its cylindrical portion, Fig.2] and a first insertion shaft [cylindrical portion of 104 and tapering distal tip portion 106, Fig.1];
the first insertion shaft having an illumination emitter [208, Fig.3a, para.41] and a solid state imaging sensor [214, Fig.3a, para.42] at or near a distal tip of the shaft, the illumination emitter and imaging sensor designed to provide illumination and imaging of an interior of a body cavity for a surgeon during surgery [abstract, para.38];
a proximal portion of the handle [portion of handle proximal to 116, Fig.5, para.40] having electronics [402, 406, Fig.5] designed to drive the illumination emitter [para.63] and to receive an imaging signal from the imaging sensor [para.62], the proximal handle portion being designed to permit sterilization of the proximal handle portion between uses [para.25, 70];
a separation joint [114, Figs.1-5] between the proximal handle portion and the first insertion shaft designed to separably connect the first insertion shaft to the proximal handle portion [Figs.1-2, 4a-b, para.40]:
when separated, the separation joint permitting removal of the first insertion shaft for disposal and replacement of the first insertion shaft [para.24]; and
when connected, the separation joint designed to provide mechanical force transfer applied by a surgeon's hand to the first insertion shaft [para.40, Figs.1-3a, 4a-b],
the separation joint having features to transfer roll torques [616, 618, 4a, para.51],
the separation joint having locking features [118, 608, Figs.4a-b, para.40, 50, 52] designed to lock the first insertion shaft and proximal handle portion of the endoscope to each other,
the separation joint having facing flat force-transmittal surfaces [602, 604, 616, 618, Figs.4a-b, para.51, “a fitted arrangement is created therebetween”] at or near a periphery of the separation joint that, when the separation joint is connected and locked, abut to transmit insertion and withdrawal forces across the separation joint, the separation joint's locking features and peripheral flat force-transmittal surfaces designed to provide stiffness in bending across the separation joint to transfer pitch and yaw torques across the separation joint [Fig.4b, para.51],
the separation joint having an electrical connector [302a-b, 304a-b, Figs.3a, 4-5, para.59] designed to provide separable electrical connectivity between the proximal handle electronics and the illumination emitter and imaging sensor;
mechanical features [602, proximal end of 114a, Figs.4a-b, para.51] of the separation joint designed to bring the peripheral flat force- transmittal surfaces together via a motion compatible with connection of the electrical connector [Fig.4b, para.51, 59]
the separation joint designed to permit removal of the first insertion shaft for disposal and replacement [para.24], the first insertion shaft having length and diameter dimensions [by definition as a physical object]; and
to reconnect a second insertion shaft at the separation joint, the second insertion shaft having at least one dimension, optical property, or configuration of the imaging sensor substantially different than the corresponding dimension, optical property, or sensor configuration of the first insertion shaft, the difference in dimension, optical property, or sensor configuration between the first and second insertion shafts specializing the first insertion shaft designed for surgery of different organs of the body different than organs to which to second insertion shaft is specialized [this second insertion shaft is not positively recited, hence one could be so used].
In regards to claim 22, Birkrant discloses the endoscope of claim 17, further comprising:
the difference in dimension, optical property, or sensor configuration between the insertion shafts specializing the first and second shafts, respectively, to different types of surgery [as the second insertion shaft is not positively recited, one could be used to satisfy this limitation].
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 34-36, 40 and 43 are rejected under 35 U.S.C. 102(b) as unpatentable over Birkrant (US 2014/0107416) in view of Krupa et al. (US 2008/0214896).
In regards to claim 34, Birkrant discloses an endoscope, comprising:
a handle [portions of 102 proximal to 116, Figs.2, 4-5, para.40] and a plurality of endoscope insertion shafts [cylindrical portion of 104 and tapering distal tip portion 106, Fig.1, para.24];
each endoscope insertion shaft having an illumination emitter [208, Fig.3a, para.41] and a solid state imaging sensor [214, Fig.3a, para.42] at or near its tip, the illumination emitter and imaging sensor designed to provide illumination and imaging of an interior of a surgical cavity for a surgeon during surgery [abstract, para.38];
a handle having electronics [402, 406, Fig.5] designed to drive the illumination emitter and to receive an imaging signal from the imaging sensor, the handle being designed to permit sterilization of the proximal handle portion between uses [para.25, 70];
a separation joint [114, Figs.1-5] between the handle and the endoscope insertion shaft designed to separably connect the endoscope insertion shaft to the handle [Figs.1-2, 4a-b, para.40]:
when separated, the separation joint permitting removal of the endoscope insertion shaft for disposal and replacement of the endoscope insertion shaft [para.24]; and
when connected, the separation joint designed to provide mechanical force transfer applied by a surgeon's hand to the endoscope insertion shaft [para.40, Figs.1-3a, 4a-b],
the separation joint having an electrical connector [302a-b, 304a-b, Figs.3a, 4-5, para.59] designed to provide separable electrical connectivity between the handle electronics and the imaging sensor.
Birkrant further discloses wherein replaceable modular components of the endoscope may have different dimensions and characteristics [Fig.6, para.66].
However, Birkrant does not positively disclose the endoscope insertion shafts of the plurality having, respectively, differing dimensions, differing optical properties, or differently-configured imaging sensors at their respective tips, the difference in dimension, optical property, or sensor configuration between the insertion shafts specializing the respective insertion shaft to, respectively, different types of surgery.
Krupa teaches an analogous endoscope [100, Fig.1, para.14, 24] with a handle [112, Fig.1, para.24] and a plurality of endoscope insertion shafts [114, Fig.1, para.14, 24],
each endoscope insertion shaft having an imaging sensor [“camera and associated optics”, “camera”, para.14, 23-24] at or near its respective distal tip, the imaging sensor to provide imaging of an interior of a surgical cavity for a surgeon during surgery [para.5, 14, 23-24, endoscopes may be used in this fashion], the endoscope insertion shafts of the plurality having, respectively, differing dimensions [para.14], the difference in dimension between the insertion shafts specializing the respective insertion shaft to, respectively, different types of surgery [para.14, by definition].
Krupa teaches that the endoscope insertion shafts with differing dimensions are provided for the purpose of providing greater flexibility to the operator.
Therefore it would have been obvious to one having ordinary skill in the art to modify the plurality of endoscope insertion shafts of the endoscope of Birkrant to have differing dimensions in accordance with the teaching of Krupa. This would be done for the purpose taught above, as well as because Krupa shows that this feature is known in the art, as well as for the predictable result of allowing the endoscope system to handle a greater variety of medical needs.
In regards to claim 35, Birkrant in view of Krupa teaches the endoscope of claim 34, wherein:
when connected, the separation joint designed to provide mechanical force transfer applied by a surgeon's hand to the insertion shaft [Birkrant: para.40, Figs.1-3a, 4a-b],
the separation joint having features to transfer roll torques [Birkrant: 616, 618, 4a, para.51],
the separation joint having locking features [Birkrant: 118, 608, Figs.4a-b, para.40, 50, 52] designed to lock the insertion shaft and proximal handle portion of the endoscope to each other,
the separation joint having facing flat force-transmittal surfaces [Birkrant: 602, 604, 616, 618, Figs.4a-b, para.51, “a fitted arrangement is created therebetween”] at or near a periphery of the separation joint that, when the separation joint is connected and locked, abut to transmit insertion and withdrawal forces across the separation joint,
the separation joint's locking features and peripheral flat force-transmittal surfaces designed to provide stiffness in bending across the separation joint to transfer pitch and yaw torques across the separation joint [Birkrant: Fig.4b, para.51].
In regards to claim 36, Birkrant in view of Krupa teaches the endoscope of claim 34, wherein:
the separation joint designed to permit removal of a first insertion shaft for disposal and replacement [Birkrant: para.24, and as the first insertion shaft is not positively claimed], the first insertion shaft having length and diameter dimensions; and
to reconnect a second insertion shaft at the separation joint, the second insertion shaft having at least one dimension substantially different than the corresponding dimension of the first insertion shaft, the difference in dimension, optical property, or sensor configuration between the first and second insertion shafts specializing the first insertion shaft for surgery of organs of the body different than organs to which to second insertion shaft is specialized [as the first and second insertion shafts are not positively set forth in this claim, such shafts could be used.].
In regards to claim 40, Birkrant in view of Krupa teaches the endoscope of claim 34, wherein:
the endoscope shafts of the plurality are respectively specialized to surgery on different parts of the body [Krupa: para.14: given the appropriate surgery. While the applicant might intend to claim something far narrower, if the applicant wishes to claim particular specialized endoscope shafts for particular surgeries, the applicant should bring details from paragraph 18 and the table thereinafter into the claim.].
In regards to claim 43, Birkrant in view of Krupa teaches the endoscope of claim 34, further comprising:
two or more endoscope insertion shafts [Birkrant: cylindrical portion of 104 and tapering distal tip portion 106, Fig.1, para.24, as modified by Krupa hereinabove. Note the related 112 (b) rejection hereinabove] having, respectively, dimensions different than the others [Krupa: para.14], each connectable to the handle at the separation joint, to permit use of the handle in surgery with different requirements for the endoscope insertion shaft [Given an appropriate surgery, shafts of different lengths as set forth by Birkrant in view of Krupa would satisfy this requirement].
Claims 34, 36, 40-41 and 43 are rejected under 35 U.S.C. 102(b) as unpatentable over Birkrant (US 2014/0107416) in view of Kimmel et al. (US 2007/0162095).
In regards to claim 34, Birkrant discloses an endoscope, comprising:
a handle [portions of 102 proximal to 116, Figs.2, 4-5, para.40] and a plurality of endoscope insertion shafts [cylindrical portion of 104 and tapering distal tip portion 106, Fig.1, para.24];
each endoscope insertion shaft having an illumination emitter [208, Fig.3a, para.41] and a solid state imaging sensor [214, Fig.3a, para.42] at or near its tip, the illumination emitter and imaging sensor designed to provide illumination and imaging of an interior of a surgical cavity for a surgeon during surgery [abstract, para.38];
a handle having electronics [402, 406, Fig.5] designed to drive the illumination emitter and to receive an imaging signal from the imaging sensor, the handle being designed to permit sterilization of the proximal handle portion between uses [para.25, 70];
a separation joint [114, Figs.1-5] between the handle and the endoscope insertion shaft designed to separably connect the endoscope insertion shaft to the handle [Figs.1-2, 4a-b, para.40]:
when separated, the separation joint permitting removal of the endoscope insertion shaft for disposal and replacement of the endoscope insertion shaft [para.24]; and
when connected, the separation joint designed to provide mechanical force transfer applied by a surgeon's hand to the endoscope insertion shaft [para.40, Figs.1-3a, 4a-b],
the separation joint having an electrical connector [302a-b, 304a-b, Figs.3a, 4-5, para.59] designed to provide separable electrical connectivity between the handle electronics and the imaging sensor.
Birkrant further discloses wherein different embodiments of modular components of the endoscope may have different dimensions and characteristics and may be interchanged for one another [Fig.6, para.66].
However, Birkrant does not positively disclose the endoscope insertion shafts of the plurality having, respectively, differing dimensions, differing optical properties, or differently-configured imaging sensors at their respective tips, the difference in dimension, optical property, or sensor configuration between the insertion shafts specializing the respective insertion shaft to, respectively, different types of surgery.
Kimmel teaches an analogous endoscope comprising: a handle [11, Figs.1-2, para.27-28, excepting 20 and the distal portion of 11 near 20, Fig.2] and a plurality of endoscope insertion shafts [different instances of 12-14, Figs.1, 5-6, 8, para.29, 44, 54, 57, abstract, excepting the proximal end 24, Fig.2, para.29: these shaft component embodiments are used as interchangeable parts];
each endoscope insertion shaft having an illumination emitter [58, Figs.5, para.40 and 72, Fig.8, para.48] and a solid state imaging sensor [14, 57, Fig.5, para.39 and 57’, Fig.8, para.48] at or near its tip, the illumination emitter and imaging sensor designed to provide illumination and imaging of an interior of a surgical cavity for a surgeon during surgery [para.1-2, 13, 26, 31, 40, 48];
the endoscope insertion shafts of the plurality having, respectively, differing dimensions [para.29], differing optical properties [para.44], or differently-configured imaging sensors at their respective tips [Figs.5-6, 8, para.48, 54, 57], the difference in dimension, optical property, or sensor configuration between the insertion shafts specializing the respective insertion shaft to, respectively, different types of surgery [as a consequence of the different functionality];
a handle having electronics designed to drive the illumination emitter [45, para.11, 32, 36, 40] and to receive an imaging signal from the imaging sensor [15, para.39, 54-55];
a separation joint [20, distal end of 11 near 20, 24 and portions thereof, Fig.2, para.29, 33] between the handle and the endoscope insertion shaft designed to separably connect the endoscope insertion shaft to the handle [Figs.1-2, para.29, 33]:
when separated, the separation joint permitting removal of the endoscope insertion shaft for disposal and replacement of the endoscope insertion shaft [para.29, 54, 57]; and
when connected, the separation joint to provide mechanical force transfer applied by a surgeon's hand to the endoscope insertion shaft [Figs.1-2, abstract, para.6, para.29: this is a property of stylets],
the separation joint having an electrical connector [30-35, Fig.2, para.32-34] designed to provide separable electrical connectivity between the handle electronics and the imaging sensor.
Kimmel teaches that the endoscope insertion shafts of the plurality have, respectively, differing dimensions, differing optical properties, or differently-configured imaging sensors at their respective tips for the purpose of examining areas from a different perspective [para.57], to facilitate insertion [para.54], and to allow rapid modification to suit a clinician’s needs [para.1].
Therefore it would have been obvious to one having ordinary skill in the art to modify the plurality of endoscope insertion shafts of the endoscope of Birkrant to have differing dimensions in accordance with the teaching of Kimmel. This would be done for the purposes taught above, as well as because Kimmel shows that this feature is known in the art, as well as for the predictable result of allowing the endoscope to handle a greater variety of medical needs.
In regards to claim 36, Birkrant in view of Kimmel teaches the endoscope of claim 34, wherein:
the separation joint designed to permit removal of a first insertion shaft for disposal and replacement [Birkrant: para.24, and as the first insertion shaft is not positively claimed], the first insertion shaft having length and diameter dimensions; and
to reconnect a second insertion shaft at the separation joint, the second insertion shaft having at least one dimension substantially different than the corresponding dimension of the first insertion shaft, the difference in dimension, optical property, or sensor configuration between the first and second insertion shafts specializing the first insertion shaft for surgery of organs of the body different than organs to which to second insertion shaft is specialized [as the first and second insertion shafts are not positively set forth in this claim, such shafts could be used. Also see Kimmel: para.29, 54, 57].
In regards to claim 40, Birkrant in view of Kimmel teaches the endoscope of claim 34, wherein: the endoscope shafts of the plurality are respectively specialized to surgery on different parts of the body [Kimmel: abstract, para.1, 8-9: given the appropriate surgery. While the applicant might intend to claim something narrower, if the applicant wishes to claim particular specialized endoscope shafts for particular surgeries, the applicant should bring details from paragraph 18 and the table thereinafter into the claim, or the like].
In regards to claim 41, Birkrant in view of Kimmel teaches the endoscope of claim 34, wherein:
the endoscope shafts of the plurality have, respectively, differently-configured imaging sensors at their respective tips [Kimmel: 57-59, Fig.5, and 57’, 59’, 67’, Fig. 8].
In regards to claim 43, Birkrant in view of Kimmel teaches the endoscope of claim 34, further comprising:
two or more endoscope insertion shafts [Birkrant: cylindrical portion of 104 and tapering distal tip portion 106, Fig.1, para.24, as modified by Kimmel hereinabove. Note the related 112 (b) rejection hereinabove] having, respectively, dimensions different than the others [Kimmel: para.29], each connectable to the handle at the separation joint, to permit use of the handle in surgery with different requirements for the endoscope insertion shaft [Given an appropriate surgery, shafts of different lengths as set forth by Birkrant in view of Kimmel would satisfy this requirement].
Claims 37-39 are rejected under 35 U.S.C. 102(b) as unpatentable over Birkrant (US 2014/0107416) in view of Krupa et al. (US 2008/0214896) and Haggerty et al. (US 2017/0078583).
In regards to claim 37, Birkrant in view of Krupa teaches the endoscope of claim 34, however does not positively teach:
a rotation joint between the handle and the endoscope insertion shaft designed to permit rotation of the endoscope insertion shaft relative to the handle in a roll dimension about a central axis of the endoscope insertion shaft.
Haggerty teaches an analogous endoscope [10, Fig.3b] having a handle [16, Fig.3b; note 15 is not part of 16], an insertion shaft [14, Fig.3b], and a separation joint [interfacing components between 12, 15, Figs.3b, 16-17] between the handle and the insertion shaft designed to separably connect the insertion shaft to the proximal part of the handle [para.110, 197],
a rotation joint [Figs.2, 3b, para.98, 112: interface between 30, 16] between the handle and the endoscope insertion shaft designed to permit rotation of the endoscope insertion shaft relative to the handle in a roll dimension about a central axis of the endoscope insertion shaft.
Therefore it would have been obvious to one having ordinary skill in the art to modify the handle used in the endoscope taught by Birkrant in view of Krupa to have a rotation joint in accordance with the teachings of Haggerty. This would be done for the predictable result of being able to roll the insertion portion without rolling the proximal handle at the same time, and as Haggerty shows that this is known in the art.
In regards to claim 38, Birkrant in view of Krupa and Haggerty teaches the endoscope of claim 37, wherein:
the handle has a rotation collar [Haggerty: 30, Fig.3b] with surface features [Haggerty: 36, Fig.3b, para.99] designed to assist the surgeon in rotating the endoscope insertion shaft relative to the handle in a roll dimension about a central axis of the endoscope insertion shaft.
In regards to claim 39, Birkrant in view of Krupa and Haggerty teaches the endoscope of claim 37, however does not positively teach wherein:
the electronics inside the handle are designed to sense roll of the endoscope insertion shaft, and to provide an angular rotation signal designed to permit righting of a displayed image received from the imaging sensor.
Haggerty further teaches wherein electronics [“(PCB) that comprises electronic
components”, sensors 430G, Fig.9b, para.148] inside the proximal handle are designed
to sense roll of the insertion shaft [para.148], and to provide an angular rotation signal
designed to permit righting of a displayed image received from the imaging sensor [para.148].
Haggerty teaches that this is done for the purpose of providing an angular
rotation signal to permit righting of a displayed image received from the imaging sensor
[para.148].
Therefore, it would have been obvious to one having ordinary skill in the art to
modify the electronics taught by Birkrant in view of Krupa and Haggerty to sense roll of the insertion shaft in accordance with the teachings of Haggerty. This would be done for the purpose taught above.
Allowable Subject Matter
Claims 23, 27-30 and 33 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112, 2nd paragraph, set forth in this Office action.
Claims 25, 42 and 44 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112, 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The
prior art fails to teach, among other features, an endoscope comprising:
a handle and an insertion shaft;
the insertion shaft comprising an illuminator and imager at or near a tip of the shaft,
the handle having electronics configured to drive the illuminator and to receive an imaging signal from the imager, the handle sterilizable between uses;
a joint between the handle and the insertion shaft configured to separably connect the insertion shaft to the proximal handle:
when separated, the joint allowing replacement of the insertion shaft; and
when connected, the joint configured to provide mechanical force transfer applied by a surgeon's hand to the insertion shaft,
the joint having an electrical connector configured to provide separable electrical connectivity from the proximal handle electronics to the illuminator and image:
further comprising an ultraviolet LED internal to the endoscope and designed to sterilize a region of an interior of the endoscope.
Kimmel et al. (US 2007/0162095) teaches the above except for the sterilizing UV LED or the handle being sterilizable.
Orbay et al. (US 2008/0195128) teaches the above except for the sterilizing UV LED, or the illumination emitter.
Irion et al. (US 2008/0300456) teaches the above except for the sterilizing UV LED, the proximal portion of the handle being sterilizable, or the illumination emitter.
Hu et al. (US 2012/0310045) teaches the above except for the sterilizing UV LED, or the proximal portion of the handle being sterilizable.
Birkrant (US 2014/0107416) discloses the above except for the sterilizing UV LED.
Ouyang et al. (US 2015/0150441) teaches the above except for the sterilizing UV LED or the proximal portion of the handle being sterilizable between uses.
Gaska et al. (US 2007/0187626) teaches a sterilization tool for use with an endoscope which has an ultraviolet LED.
There is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kimmel et al. (US 2007/0162095)
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON B FAIRCHILD whose telephone number is (571)270-5276. The examiner can normally be reached 8:30am-5pm Monday-Friday.
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, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AARON B FAIRCHILD/Primary Examiner, Art Unit 3795