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 .
Applicant’s arguments filed in the reply on May 26, 2026, 2024 were received and fully considered. Claims 2-6, 12, and 14 were amended. Claims 21-24 were added. Please see below for more detail.
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
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 for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that 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. Such claim limitations is/are:
(Claim 1) “at least one fluid wicking element, positioned on the imaging system proximate to the camera lens of the imaging capsule to enable the fluid wicking element to wick liquid away from the camera lens.”
(Claim 7) “at least one alignment element for aligning the imaging system when inserted in an opening.”
(Claim 13) “at least one alignment element attached on the imaging system to enable a positioning of the imaging system in an opening.”
(Claim 16) “the at least one alignment element is positioned on the imaging system proximate to the camera lens of the imaging capsule to enable the at least one alignment element comprising the fluid wicking properties to wick liquid away from the camera lens”
(Claim 17) “a restraining element to collapse the at least one alignment element”
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
(Claim 1) “at least one fluid wicking element, positioned on the imaging system proximate to the camera lens of the imaging capsule to enable the fluid wicking element to wick liquid away from the camera lens.” As identified by the Specification, the following is recognized as the corresponding structure to the alignment element: “Figure 1A depicts a high-level block diagram of an imaging system in accordance with an embodiment of the present principles. The imaging system 100 of Figure 1A illustratively comprises an esophageal imaging capsule including an imaging capsule 1 having a tapered first end 2 ending in a tether 3, a camera lens 4 on a second end, and a drain wick attached to the imaging capsule 1 near the camera lens 4. In some embodiments, the drain wick 5 can comprise a filament with hydrophilic properties that tends to attract droplets of liquid (e.g., water) that may otherwise stay attached the lens. That is, is some embodiments, the drain wick 5 can be used to attract liquid droplets away from and off of the lens 4. Gravity and wicking can both be implemented to pull the liquid droplets along the wick where the liquid droplets can either drop off freely or be pulled away by making contact with an absorbent material, such as a tissue.” Or equivalents thereof.
(Claim 7) “at least one alignment element for aligning the imaging system when inserted in an opening.” / (Claim 13) “at least one alignment element attached on the imaging system to enable a positioning of the imaging system in an opening.” As identified by the Specification, the following is recognized as the corresponding structure to the alignment element: “In some embodiments, various protuberant devices/positioning mechanisms such as fins, wire loops, splaying filaments, etc. can be attached to a palatant or a tether of an imaging system of the present principles. The arms of such protuberant devices/positioning mechanisms can be specialized to provide alignment for an imaging system of the present principles and can emerge more proximally.” Or equivalents thereof.
(Claim 16) “the at least one alignment element is positioned on the imaging system proximate to the camera lens of the imaging capsule to enable the at least one alignment element comprising the fluid wicking properties to wick liquid away from the camera lens”: As identified by the Specification, the following is recognized as the corresponding structure to the alignment element: “However, the properties of a drain wick of the present principles and an alignment extension of the present principles can be combined to form at least one drain wick/alignment extension in accordance with the present principles. For example, in Figure 7 the drain wicks/alignment extensions 75a, 75b, 75c, and 75d comprise hydrophilic properties and are attached to the bottom of the imaging capsule 71 near the camera lens 74 to wick moisture away from the camera lens 74. The drain wicks/alignment extensions 75a, 75b, 75c, and 75d also provide rigidity and stability for enabling a positioning of the imaging system 700 and can comprise properties of the alignment extensions as described above with reference to the imaging system 600 of Figure 6.” Or equivalents thereof.
(Claim 17) “a restraining element to collapse the at least one alignment element”: As identified by the Specification, the following is recognized as the corresponding structure to the restraining element: “In some embodiments, a band can be wrapped around collapsed alignment extensions to keep the alignment extensions in the collapsed form. When the band is released, the alignment extensions can then spring into a more radial pattern. In some embodiments, the band can be made of water-soluble material - where the material takes sufficient time to dissolve so as to allow the passage of the device beyond the palate before the material dissolves. In alternate embodiments, another approach can be to use a material that melts at body temperature, such as gelatin, to keep the alignment extensions in the collapsed form (i.e., via a sleeve or band). After being swallowed, the material can melt and the alignment extensions can then spring into a more radial pattern.” Or equivalents thereof.
If applicant wishes to provide explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 13-15 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rachlin et al (US 2015/0289752) (“Rachlin”).
Regarding Claim 13, Rachlin teaches an imaging system according to a first embodiment, comprising:
a tether (Fig. 1A, [0078] flexible tether 13);
a tapered end portion coupling the tether to an imaging capsule (Fig. 1A, [0078] intermediate portion 12 shown in the Figure to be tapered);
the imaging capsule comprising a camera lens (Fig. 1A, [0078] imaging capsule 11, [0081] camera with lens); and
at least one alignment element attached on the imaging system to enable a positioning of the imaging system in an opening (Figs. 9-10, [0078], [0081] imaging system can include a camera with lens, Fig. 2A, [0090] details an example lens assembly 204 of the camera, [0111], [0116] sponge acts as an alignment element).
Alternatively, Rachlin teaches an imaging system according to a second embodiment, comprising the tether, tapered end portion, and imaging capsule as outlined above, and
at least one alignment element attached on the imaging system to enable a positioning of the imaging system in an opening (Figs. 7-8, [0078], [0081] imaging system can include a camera with lens, Fig. 2A, [0090] details an example lens assembly 204 of the camera, [0114]-[0115] flexible fins 704a, 704b, and 704c / alignment elements as part of a sleeve attached on the imaging capsule 705 / imaging system to support center alignment of the capsule).
Regarding Claim 14, Rachlin teaches the imaging system according to a second embodiment of claim 13, further comprising a palatant, wherein the at least one alignment element is positioned to maintain the position of the palatant on the imaging capsule ([0115] palatant sleeve 701 is aligned by flexible fins protruding from the central body).
Regarding Claim 15, Rachlin teaches the imaging system according to a second embodiment of claim 13, wherein the at least one alignment element comprises fluid wicking properties (Figs. 7-10, [0111], [0116] the sponge also acts as a fluid wicking element, positioned on the imaging system proximate to the camera lens of the imaging capsule by surrounding the imaging capsule as shown in Fig. 8-9).
Regarding Claim 17, Rachlin teaches the imaging system according to a second embodiment of claim 13, further comprising a restraining element to collapse the at least one alignment element ([0116] palatant sleeve capsule restrains alignment element / sponge).
Regarding Claim 18, Rachlin teaches the imaging system according to a second embodiment of claim 17, wherein the at least one alignment element is collapsed by the restraining element to enable placing the imaging system into an opening (See Claim 17 Rejection, [0116] sponge is collapsed by palatant sleeve / restraining element to enable placing the imaging system into the esophagus opening).
Regarding Claim 19, Rachlin teaches the imaging system according to a second embodiment of claim 18, wherein the restraining element is removed and the at least one alignment element expands after entering the opening (See Claim 18 Rejection, the palatant sleeve is removed and the at least one alignment element / sponge expands after enter the esophagus opening).
Regarding Claim 20, Rachlin teaches the imaging system according to a second embodiment of claim 18, wherein the at least one alignment element is constructed of materials having such fine proportions that forces exerted on surfaces of the opening by the at least one alignment element are insufficient to impede the passage of the imaging system through the opening when the imaging system is pulled by gravity ([0080], [0111] tether flexibility and size of expanded alignment element should promote gravity-assisted descent, indicating that the expanded alignment is constructed of materials having such fine proportions that forces exerted on the walls of the esophagus by the sponge alignment element are insufficient to impede the passage of the imaging system as directed by gravity).
Claim(s) 1-2 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cutrale (WO 2022/211820).
Regarding Claim 1, Cutrale teaches an imaging system (Abstract), comprising:
a tether (Fig. 1A, [069] tether 104);
a tapered end portion coupling the tether to an imaging capsule (Fig. 1A, [069] tapered end portion of imaging capsule 102 is the rounded distal capsule end connecting to tether 104);
the imaging capsule comprising a camera lens (Fig. 1A, [058], [061], [071], [076] imaging sensor 109 is a camera with a lens 122); and
at least one fluid wicking element, positioned on the imaging system proximate to the camera lens of the imaging capsule (Fig. 4A-4D, [093]-[094] textured surfaces act as fluid wicking elements, positioned on the imaging capsule 102 proximate to a camera lens of the imaging capsule and acts to suction water away from the direction of the lens of the imaging capsule 102) to enable the fluid wicking element to wick liquid away from the camera lens ([093]-[094]).
Regarding Claim 2, Cutrale teaches the imaging system of claim 1, wherein the at least one fluid wicking element uses at least one of a wicking property of a material of the at least one fluid wicking element or gravity to wick liquid away from the camera lens (See Claim 1 Rejection, textured surface acts to suction water away, thus exhibiting a wicking property).
Regarding Claim 5, Cutrale teaches the imaging system of claim 1, wherein the at least one fluid wicking element comprises a drain wick (See Claim 1 Rejection, textured surface acts to suction water away, thus acting as a drain wick).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-9, 11-12, 16, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rachlin in view of Ohnmacht (US 2018/0221052).
Regarding Claim 1, while Rachlin teaches an imaging system (Abstract), comprising:
a tether (Fig. 1A, [0078] flexible tether 13);
a tapered end portion coupling the tether to an imaging capsule (Fig. 1A, [0078] intermediate portion 12 shown in the Figure to be tapered);
the imaging capsule comprising a camera lens (Fig. 1A, [0078] imaging capsule 11); and
at least one fluid wicking element, positioned on the imaging system proximate to the camera lens of the imaging capsule (Figs. 9-10, [0078], [0081] imaging system can include a camera with lens, Fig. 2A, [0090] details an example lens assembly 204 of the camera, [0049]-[0051] in one embodiment for a fluid wicking element, a hydrophilic coating may be placed on the tether, capsule, and/or sleeve, [0111], [0116] in another embodiment, a palatant sleeve of sponge acts as a fluid wicking element, where both fluid wicking elements are positioned on the imaging system proximate to the camera lens of the imaging capsule by surrounding the imaging capsule as shown in Fig. 8-9) where the fluid wicking element’s position would enable a wicking action away from the camera lens (teaches the intended use limitation). Alternatively Rachlin fails to explicitly disclose the positioning action being done to enable the fluid wicking element to wick liquid away from the camera lens.
However Ohnmacht teaches a endoscopic system (Abstract) wherein a distal imaging end endoscopic system comprises at least one fluid wicking element, positioned on the imaging system proximate to the camera lens of the imaging capsule to enable the fluid wicking element to wick fluid away from the camera lens (Figs. 3 and 5, [0027]-[0030] “The elongate woven fabric wick 32 occupies a majority of the lumen 34 and is sized accordingly to be contained therein, too thick to pass through slot 36, and effectively trapped within lumen 34 yet frontally exposed through slot 36. This leaves wick 32 free to absorb blood or fluid running down its length. The woven fabric wick 32 preferably remains slidable within lumen 34 and may be removed, if desired, or extended from exterior of the body. In is normal position the woven fabric wick 32 extends outward from lumen 34 at the distal tip of cannula 2 and arcs downward under natural force of gravity approximately an inch or two. This way, when cannula 2 is used as a surgical port for an endoscope and the endoscope protrudes through cannula 2 into the thoracic cavity, any residual blood or fluid running down cannula 2 under force of gravity will either be absorbed into the woven fiber of the wick 32 or directed down the wick 32 away from the endoscopic lens and/or surgical site, thereby helping to maintain a clear field-of-view through the endoscope.“ fluid wicking element / blood wicking/diversion mechanism 30 is positioned proximate an endoscope lens, enabling fluid wicking away from the endoscope lens. Further, the wick may be formed as a sleeve around the endoscope end as taught in Fig. 5’s blood wicking/diversion mechanism 130 with an extending wick 132 acting to absorb fluid through gravity as taught in the first embodiment. In both cases, the wicking mechanism is positioned to enable the fluid wicking element to wick liquid away from the camera lens).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the tethered endoscopic visualization system of Rachlin to configure the fluid wicking sponge sleeve to further comprise a fluid wicking diversion mechanism as taught by Ohnmacht to enable the fluid wicking away from the endoscope lens as this maintains a clear field-of-view through the endoscope. Furthermore, it would be obvious to use Rachlin’s sponge sleeve in conjunction with the wicking sleeve and end of Ohnmacht as the absorbing of fluid provided by the woven fabric would also be accomplished with Rachlin’s sponge sleeve, while also providing the alignment benefit of Rachlin.
Regarding Claim 2, Rachlin and Ohnmacht teach the imaging system of claim 1, wherein the at least one fluid wicking element uses at least one of a wicking property of a material of the at least one fluid wicking element or gravity to wick liquid away from the camera lens (See Claim 1 Rejection).
Regarding Claim 3, Rachlin and Ohnmacht teach the imaging system of claim 1, wherein the wicked fluid can accumulate on the at least one fluid wicking element and be drawn off of the at least one fluid wicking element by gravity (See Claim 1 Rejection, Ohnmacht’s wick connected to Rachlin’s sponge has this functionality as in [0027] of Ohnmacht).
Regarding Claim 4, Rachlin and Ohnmacht teach the imaging system of claim 1, wherein fluid accumulated on the at least one fluid wicking element is drawn off by contact with a surrounding absorbent material (See Claim 1 Rejection, the combination of Rachlin’s sponge sleeve over Ohnmacht’s wick would lead to a first fluid wicking element of Ohnmacht having fluid accumulated by contact with a surrounding absorbent material/second fluid wicking element/Rachlin’s sponge so that the sponge may provide alignment capabilities).
Regarding Claim 5, Rachlin and Ohnmacht teach the imaging system of claim 1, wherein the at least one fluid wicking element comprises a drain wick (See Claim 1 Rejection, Ohnmacht: by draining fluid away from the lens).
Regarding Claim 6, Rachlin and Ohnmacht teach the imaging system of claim 1, and Rachlin teaches wherein the at least one fluid wicking element further functions as an alignment element for the imaging system ([0111], [0116] at least one of the wicking elements, i.e. the sponge of Rachlin, further acts as an alignment element when the sponge comprises fins as shown in Figs. 8-9).
Regarding Claim 7, Rachlin and Ohnmacht teach the imaging system of claim 1, and Rachlin teaches the imaging system further comprising at least one alignment element for aligning the imaging system when inserted in an opening ([0111], [0116] at least one of the wicking elements, i.e. the sponge of Rachlin, further acts as an alignment element when the sponge comprises fins as shown in Figs. 8-9).
Regarding Claim 8, Rachlin and Ohnmacht teach the imaging system of claim 7, wherein the opening comprises a human esophagus (See Claim 1 Rejection).
Regarding Claim 9, Rachlin and Ohnmacht teach the imaging system of claim 7, and Rachlin teaches the imaging system wherein the at least one alignment element comprises three alignment elements to center the imaging system in the opening ([0111], [0116] at least one of the wicking elements, i.e. the sponges of Rachlin, further acts as three alignment element when the sponge comprises fins as shown in Figs. 8-9).
Regarding Claim 11, Rachlin and Ohnmacht teach the imaging system of claim 7, wherein the at least one alignment element comprises fluid wicking properties (See Claim 7 Rejection).
Regarding Claim 12, Rachlin and Ohnmacht teach the imaging system of claim 1, wherein the at least one fluid wicking element comprises at least one of a hydrophilic or lubricious coating (See Claim 1 Rejection, Rachlin’s hydrophilic coating on the sleeve).
Regarding Claim 24, Rachlin and Ohnmacht teach the imaging system of claim 7, and Rachlin teaches wherein the at least one alignment element is attached to the imaging system without adhesive ([0102], [0106]-[0107] sleeves applied to imaging system may be added with many locking mechanisms that include a friction fit, Fig. 13, [0122] secondary tether string 1305) .
Regarding Claim 16, while Rachlin teaches the imaging system of claim 15, wherein the at least one alignment element is positioned on the imaging system proximate to the camera lens of the imaging capsule (See Claim 15 Rejection), where the at least one alignment element’s position would enable a wicking action away from the camera lens (meets the intended use language). Alternatively Rachlin fails to explicitly disclose the positioning action being done to enable the alignment element to wick liquid away from the camera lens.
However Ohnmacht teaches a endoscopic system (Abstract) wherein a distal imaging end endoscopic system comprises at least one fluid wicking element, positioned on the imaging system proximate to the camera lens of the imaging capsule to enable the fluid wicking element to wick fluid away from the camera lens (Figs. 3 and 5, [0027]-[0030] “The elongate woven fabric wick 32 occupies a majority of the lumen 34 and is sized accordingly to be contained therein, too thick to pass through slot 36, and effectively trapped within lumen 34 yet frontally exposed through slot 36. This leaves wick 32 free to absorb blood or fluid running down its length. The woven fabric wick 32 preferably remains slidable within lumen 34 and may be removed, if desired, or extended from exterior of the body. In is normal position the woven fabric wick 32 extends outward from lumen 34 at the distal tip of cannula 2 and arcs downward under natural force of gravity approximately an inch or two. This way, when cannula 2 is used as a surgical port for an endoscope and the endoscope protrudes through cannula 2 into the thoracic cavity, any residual blood or fluid running down cannula 2 under force of gravity will either be absorbed into the woven fiber of the wick 32 or directed down the wick 32 away from the endoscopic lens and/or surgical site, thereby helping to maintain a clear field-of-view through the endoscope.“ fluid wicking element / blood wicking/diversion mechanism 30 is positioned proximate an endoscope lens, enabling fluid wicking away from the endoscope lens. Further, the wick may be formed as a sleeve around the endoscope end as taught in Fig. 5’s blood wicking/diversion mechanism 130 with an extending wick 132 acting to absorb fluid through gravity as taught in the first embodiment. In both cases, the wicking mechanism is positioned to enable the fluid wicking element to wick liquid away from the camera lens).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the tethered endoscopic visualization system of Rachlin to configure the fluid wicking sponge sleeve to further comprise a fluid wicking diversion mechanism as taught by Ohnmacht to enable the fluid wicking away from the endoscope lens as this maintains a clear field-of-view through the endoscope. Furthermore, it would be obvious to use Rachlin’s sponge sleeve in conjunction with the wicking end of Ohnmacht as the absorbing of fluid provided by the woven fabric would also be accomplished with Rachlin’s sponge sleeve, while also providing the alignment benefit of Rachlin.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rachlin in view of Ohnmacht and further in view of Bob et al (US 2006/0149130) (“Bob”).
Regarding Claim 10, Rachlin and Ohnmacht teach the imaging system of claim 7, wherein the at least one alignment element is configured as a fin having at least a surface attachment to components of the imaging system (See Claim 7 Rejection, Rachlin Fig. 8), their combined efforts fail to teach the at least one alignment element is configured as a loop having at least two attachments to components of the imaging system.
However Bob teaches an endoscope system (Abstract) comprising a loop alignment element having at least attachments to components of the imaging system (Figs. 4 and 7, [0047] optical system, [0054]-[0059], [0073]-[0074] cage 18 and loops 18a at the distal end of the guidewire to facilitate positioning of the systems along the canal-shaped cavity being explored) and further teaches that the placement of the loop may be variable as long as it assists propulsion of the endoscope ([0074]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the fin of Rachlin to be replaced with a loops with at least two attachment to components of an imaging system as Bob teaches that loops are another expandable form of guidance in a canal-shaped cavity for an endoscope. Thus it would have been a simple substitution of form of alignment element for another to obtain predictable results. Furthermore, it would have been obvious that the alignment element on the imaging system and variability of placement of the loops in Bob support loops being placed around the endoscope head. Finally, it would have been obvious that loops in this manner require at least two attachments to support a rounded structure from which to expand from the imaging system.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rachlin in view of Ohnmacht and further in view of Thommen et al (US 2021/0186316) (“Thommen”).
Regarding Claim 21, while Rachlin and Ohnmacht teach the imaging system of claim 14, and Rachlin teaches at least one alignment element extends radially (See Claims 1 and 7 Rejections, Fig. 7, [0115]-[0116] fins), and Ohnmach teaches at least one element extending radially within the body (Fig. 6, [0031] an expanding silicone hood to maintain a clear field of view by obstructing blood from reaching cannula), their combined efforts fail to teach wherein the at least one alignment element extends radially from a distal end of the imaging capsule, thereby preventing the palatant from sliding distally along the imaging capsule.
However Thommen teaches an internal imaging system (Abstract) where a distal end of the imaging system comprises at least one alignment element that extends radially (Figs. 26A-26C, [0190]-[0193] the distal end of the system comprises shielding structure that may protrude distally from the distal end surface, may expanded around the periphery of the imaging system, may be used to align the lens optimally in relation to surrounding tissue by preventing inadvertent contact with lens).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the imaging system of Rachlin to further include at least one alignment element extends radially from a distal end of the imaging capsule as taught by Thommen for the endoscopic end of the capsule to maintain an optimal relationship with the surrounding tissue. Furthermore, by nature of this alignment element being at the distal end and the sleeve alignment elements of Rachlin being placed proximally, the alignment element will block the palatable sleeve of Rachlin from sliding distally along the imaging capsule as the alignment element will already be in this position.
Allowable Subject Matter
Claim(s) 22-23 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s amendments and arguments filed 5/26/2026 with respect to the claim objections have been fully considered and are persuasive. The objection(s) is/are withdrawn.
Applicant’s acknowledgement filed 5/26/2026 with respect to the 35 USC 112(f) interpretation is recognized.
Applicant’s amendments and arguments filed 5/26/2026 with respect to the 35 USC 102(a)(1) rejection of Claim 13 have been fully considered, but are not persuasive.
Applicant argues that in regards to the 35 USC 102(a)(1) rejections of Claim 13, Rachlin fails to teach an “alignment element attached on the imaging system to enable a position of the imaging system in an opening.” As the sponge is not a structural element that affirmatively enables positioning of the imaging system in the lumen. Rachlin’s sponge has different functions, but has no “fins, protuberances, loops, filaments, or structural projections” to affirmatively guide or center the imaging capsule. Examiner respectfully disagrees. Examiner notes that under the broadest reasonable interpretation of the claim, any structure that supports alignment is an alignment element and particular structural projections are not required by the claim. Rachlin teaches that the expanded diameter of released structure enables their alignment ability ([0114]-[0015]). And Rachlin immediately goes on to say that the sponge’s expansion provides this same alignment ability as other projecting structures, i.e. the fins ([0116]). With these teachings, Examiner maintains that the sponge is an alignment element in and of itself by the nature of it’s expansion. The use of a fin structure with the sponge is not argued by the Examiner in the 35 USC 102(a)(1) rejection of Claim 13.
Applicant argues that the 35 USC 112(f) corresponding structure for the alignment element are structures that have defined geometric profiles designed to contact the lumen wall and center the capsule. Examiner will note that 35 USC 112(f) interpretations are directed towards a positive affirmation of implied structure within the disclosure from Applicant, and is separate from the broadest reasonable interpretation of the claim language. Further, the expanded diameter of the sponge maintains the central endoscope a predefined distance away from the lumen walls and thus does center the capsule.
Applicant then argues that in regards to the 35 USC 102(a)(1) rejections of Claims 17-20, the limitation of a “restraining element to collapse the at least one alignment element.” Is not met as the alignment element has not been taught for the reasons given above. Examiner respectfully disagrees for the reasons given above.
Applicant then argues that in regards to the 35 USC 102(a)(1) rejections of Claim 1, Cutrale fails to anticipate the claim limitations as Cutrale fails to teach a “fluid wicking element positioned on the imaging system proximate to the camera lens to enable fluid wicking element to wick fluid away from the camera lens” as recited in Claim 1. Specifically, the textured surface of Cutrale is an integral feature of the capsule cover and not a distinct structural element placed in proximity to the camera lens for wicking such as the drain wick described in the Specification. Examiner respectfully disagrees. The capsule cover 160 is a distinct structural element placed in proximity to the camera lens of capsule 102 by being applied over the entirety of the capsule 102. And one of the reasons for the placement of the cover 160 is for wicking fluid away from the lens of the imager of the capsule ([093]). And as stated previously, Examiner will note that 35 USC 112(f) interpretations are directed towards a positive affirmation of implied structure within the disclosure from Applicant, and is separate from the broadest reasonable interpretation of the claim language.
Applicant then argues that the effective suctioning of water by Cutrale’s textured surface is distinct from a wicking mechanism claimed as wicking is a capillary action that transports liquid along a structure. Examiner respectfully disagrees. The verb “wick” can be understood more broadly than just the “draining of fluid by a wick,” and can be understood as “draining of fluid” (Wick Definition & Meaning - Merriam-Webster, www.merriam-webster.com/dictionary/wick. Accessed 15 Aug. 2026.). Further, the claim language is of a “wicking element” not a wick itself. By this language, the interpretation can be broader and the claim can be met by an element that shares properties with a wick, such as the cover with textured surfaces draining fluid away from the imaging components.
Applicant next argues that Cutrale’s wicking element is not “positioned proximate to the camera lens.” The placement of Cutrale’s wicking element must be adjacent to the camera lens to enable the movement of fluid. Examiner respectfully disagrees. The term “proximate” has not been given specific bounds and is therefore interpreted broadly. Applicant’s argument aligns with the wicking element being placed at the distal tip of the capsule, but this is not the claim language. And as noted in Cutrale, the side placement of the textured surface draws fluid away from the lens of the imager ([094]) and therefore the claim language is met.
Applicant argues on page 13 of the Remarks that Rachlin and Ohnmacht are non-analogous are and their combination is improper as Rachlin is directed to a tethered esophageal endoscope for gastrointestinal diagnostic imaging and Ohnmacht is directed an anti-fouling thoracic surgical cannula designed to prevent blood from running down the cannula onto an endoscope. Examiner respectfully disagrees. Both inventions are directed to endoscopes. Both systems recognize that an issue endoscopes face is the fluid of the internal environment obstructing imaging by the endoscope. While Ohnmacht is in the field of surgical instrumentation for thoracic surgery, that thoracic surgery includes imaging-based diagnostic screening. One of ordinary skill in the art would be readily consult how different procedures involving endoscopes prevent or compensate for obstructed imaging due to the internal environment of a patient.
Applicant argues on page 14 of the Remarks that Rachlin and Ohnmacht would not have been obviously combined as Ohnmacht’s two embodiments are incompatible with Rachlin as a woven fabric wick running along the length of the capsule or adding a slidable tubular sleeve over Rachlin’s imaging capsule would fundamentally alter the design and function of Rachlin’s device that would undermine its palatability, swallowability, and patient comfort objectives. Examiner respectfully disagrees. First Examiner will affirm that the second embodiment of Ohnmacht was the basis of a combination with Rachlin. And Examiner considers a teaching of the woven fabric wick within a tubular sleeve over an imaging capsule would be obviously applicable from the teachings of Rachlin as Rachlin already teaches a sliding tubular sleeve in the form of the palatant sleeve and the sponge cylinder (Rachlin: [0116]). Therefore, Rachlin could easily incorporate the wick by making the tubular sleeve containing the wick the sponge/palatant sleeve of Rachlin without fundamentally altering the design or function of Rachlin’s device.
Applicant argues on pages 14-15 of the Remarks that Ohnmacht’s wick is designed to address blood, a viscous protein containing fluid that clots that is distinct from the aqueous droplets encountered by Rachlin and therefore would not looked at by one of ordinary skill in the art. Examiner respectfully disagrees. While one of ordinary skill in the art may stop to consider the material of a wick and thickness of the wick when considering the desired absorption characteristics for the different monitoring environments of the esophagus and the thoracic cavity, the utility of the wicking mechanism in keeping the lens clear would be clearly understood by Rachlin and applicable to the imaging of Rachlin’s endoscope.
Applicant argues on page 15 of the Remarks that the mere fact that both references involve maintaining a clear endoscopic field of view does not establish that a person of ordinary skill in the art would combine the specific structural teachings in the manner proposed. Examiner respectfully disagrees for the reasons given above that reflect that adding the structure of Ohnmacht to Rachlin is the result of predictable combination.
Applicant argues on pages 15-16 of the Remarks that neither Rachlin or Ohnmacht teach the claimed fluid wicking element positioned proximate to the camera lens, Applicant reiterating arguments against Cutrale on page 12 of the Remarks. Examiner respectfully disagrees for equivalent reasons in relation to the broadness of the term “proximate.”
Applicant argues on page 16 of the Remarks that the rejection of Claim 10 should be withdrawn in view of the above arguments above. Examiner respectfully disagrees for the reasons given above.
Applicants argues on pages 16-17 of the Remarks that Claim 10 is not rendered obvious by the addition of Bob’s cage and loops as Bob’s teachings are of guidance aids for advancing an endoscope shaft as opposed to the loop alignment element having at least two attachments to components of an imaging capsule to center and stabilize the capsule within the lumen. Examiner respectfully disagrees. The use of an expanded diameter components for alignment is already present in Rachlin and Bob is just showing a different design for an expanded diameter component acting as a guidance aid.
Applicants argues on page 17 of the Remarks that the references of Rachlin, Ohnmacht, and Bob would require impermissible hindsight as they are three fundamentally different device addressing fundamentally different problems. Examiner respectfully disagrees. All three references utilize endoscopes and Ohnmacht and Bob provide teachings to Rachlin on alternative steps to improve functioning in the endoscope. For this and the reasons given previously, Examiner maintains the combination is obvious and the rejections stand.
Applicant’s amendments filed 5/26/2026 with respect to the 35 USC 102(a)(1) rejection of Claim 14 have been fully considered, and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a second embodiment in Rachlin.
Conclusion
THIS ACTION IS MADE FINAL. 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 JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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, Jacqueline Cheng can be reached at (571)272-5596. 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.
/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights