DETAILED ACTION
This action is responsive to the RCE filed 2/5/26.
Claims 45-66, 75-82 are rejected.
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 (i.e., changing from AIA to pre-AIA ) 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.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 45-66, 75-82 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 45, 75 and 80, there is no support in the original disclosure for the limitations of:
‘changing the distance between the first lumen and the second lumen […].’
‘changing the distance between the second lumen and the fillable space […]’
The original disclosure describes multi-lumen tubes and inflatable balloons, but contains no disclosure of actively altering or changing a physical distance between lumens or between a lumen and a balloon/volume inside an organ.
Applicant argues that support is derived from pars. 57-60 and figs. 9-10 of the original disclosure. However, the examiner does not agree with applicant that the provided paragraphs support the above limitations and therefore the rejection is maintained.
Further regarding claims 45, 75, and 85, there is no support in the original disclosure for the limitations of “forming a bend in the second lumen such that an apex of the bend is adjacent the fillable volume within the second organ”. The specification describes catheters that passively conform to the GI tract curvature, but provides no support for a method step of actively forming a bend in a second lumen inside an organ, nor for forming an apex adjacent to a fillable volume.
Further regarding claims 45, 75 and 80, the original disclosure does not adequately support the genus limitation of a “fillable volume”. For instance, the specification only supports a single species of the genus of “fillable volumes”, i.e. a balloon. Considering the wide variety of elements that could fall within the category of fillable volumes, it is the examiner’s position that the disclosure of a single species of fillable volumes fails to adequately demonstrate that the inventor had possession of the invention comprising the entire genus of “fillable volumes” at the time that the invention was filed.
Further regarding claims 45, 75 and 80, similar to above the original disclosure does not adequately support the genus limitations of a ‘first organ’, a ‘second organ’, and a ‘third organ’. For instance, the original disclosure only provides support for the specific organs of the pancreas, stomach, and small intestine (duodenum and jejunum) which correspond respectively to the claimed first, second and third organs. There is no indication that applicant had possession of a method applicable to body organs generically beyond the specifically disclosed gastrointestinal context. Therefore, the claim fails to comply with the written description requirement.
Regarding claim 46, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that the ‘changing the distance between the first lumen and the second lumen’ occurs ‘while a distal terminal end of the first lumen and a distal terminal end of the second lumen are in the second organ.’ There is likewise no support for this additional limitation in the original disclosure.
Regarding claim 47, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that the ‘changing the distance between the first lumen and the second lumen’ further comprises ‘increasing or decreasing a distance between a proximal portion of the inserted portion of the first lumen and a proximal portion of the inserted portion of the second lumen while the proximal portion of the inserted portion of the first lumen and the proximal portion of the inserted portion of the second lumen are in the second organ.’ There is no support for this additional limitation in the original disclosure.
Regarding claim 48, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that ‘changing the distance between the first lumen and the second lumen’ further comprises ‘increasing the distance between the first lumen and the second lumen.’ There is no support for this additional limitation in the original disclosure.
Regarding claim 49, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that ‘changing the distance between the second lumen and the fillable space’ further comprises ‘increasing the distance between the second lumen and the fillable space.’ There is no support for this additional limitation in the original disclosure.
Regarding claim 50, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that ‘changing the distance between the first lumen and the second lumen’ further comprises ‘decreasing the distance between the first lumen and the second lumen.’ There is no support for this additional limitation in the original disclosure.
Regarding claim 51, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that ‘changing the distance between the second lumen and the fillable space’ further comprises ‘decreasing the distance between the second lumen and the fillable space.’ There is no support for this additional limitation in the original disclosure.
Regarding claim 52, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that ‘changing the distance between the first lumen and the second lumen’ further comprises ‘moving of the first lumen away from the first organ while the fillable space proximal end and the fillable space distal end are in the second organ’. There is no support for this additional limitation in the original disclosure.
Regarding claim 54, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that ‘changing the distance between the second lumen and the fillable space’ further comprises ‘moving the second lumen away from the first organ while the fillable space proximal end and the fillable space distal end are in the second organ.’ There is no support for this additional limitation in the original disclosure.
Regarding claim 56, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that ‘changing the distance between the first lumen and the second lumen’ further comprises ‘moving the first lumen toward the first organ while the fillable space proximal end and the fillable space distal end are in the second organ.’ There is no support for this additional limitation in the original disclosure.
Regarding claim 58, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that ‘changing the distance between the second lumen and the fillable space’ further comprises ‘moving the second lumen toward the first organ while the fillable space proximal end and the fillable space distal end are in the second organ.’ There is no support for this additional limitation in the original disclosure.
Regarding claim 63, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that ‘changing the distance between the first lumen and the second lumen’ further comprises ‘increasing a distance between the first lumen and a third lumen in the second organ while the fillable space proximal end and the fillable space distal end are in the second organ.’ There is no support for this additional limitation in the original disclosure.
Regarding claim 64, the claim further modifies the new matter limitation addressed with respect to claim 45, above, that ‘changing the distance between the first lumen and the second lumen’ further comprises ‘decreasing a distance between the first lumen and a third lumen in the stomach second organ while the fillable space proximal end and the fillable space distal end are in the second organ.’ There is no support for this additional limitation in the original disclosure.
Regarding claims 65-66, the claim recites the non-original limitations of:
‘withdrawing a retainer from the stomach’
‘wherein before the retainer is withdrawn, the fillable space has a first shape, and wherein after the retainer is withdrawn, the fillable space has a second shape different than the first shape’
There is no support for these limitations in the original disclosure in such a way that reasonably conveys that the inventor(s) had possession of the claimed invention at the time that the invention was filed. Applicant argues that support is derived from pars. 57-60 of the original disclosure. However, the examiner does not agree with applicant that the provided paragraphs support the above limitations and therefore maintains that they comprise ‘new matter’.
Regarding claims 78 and 82, the claims recite the non-original limitation of ‘wherein the first lumen and the second lumen are farther from each other in the stomach when the first lumen and the second lumen are in a first deployed configuration in the stomach than when the first lumen and the second lumen are in a second deployed configuration in the stomach.’ There is no support for this limitation in the original disclosure, therefore the claims contain ‘new matter’.
Regarding claims 79 and 82, the claims recite the non-original limitation of ‘wherein the first lumen and the second lumen are closer to each other in the stomach when the first lumen and the second lumen are in a first deployed configuration in the stomach than when the first lumen and the second lumen are in a second deployed configuration in the stomach.’ There is no support for this limitation in the original disclosure, therefore the claims contain ‘new matter’.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 45-66, 75-82 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 45, 75, and 80, the claims are indefinite because they fail to clearly define any structural relationships or interconnections between the claimed components. For instance, the claim preamble recites “a catheter”, while the body of the claim further recites “a first lumen”, “a second lumen”, and “fillable volume”. However, the claim completely fails to recite how any of these elements are structurally integrated with one another or with the catheter. It is unclear whether the first lumen, the second lumen, and the fillable volume form discrete parts of a single integrated system, or whether they represent separate, unattached components. It is further unclear whether these structural elements represent elements of the ‘catheter’ recited in the preamble or whether they represent elements which are distinct from the claimed catheter.
Further, because no structural or mechanical relationship is defined between the ‘first lumen’, the ‘second lumen’ and the ‘fillable volume’, the steps that require ‘changing a distance’ between these recited elements render the claim indefinite, as POSITA cannot determine what structural mechanisms perform or enable these changes inside the organ.
Further regarding claims 45, 75, and 80, the claims are indefinite because the limitations requiring ‘changing a distance between the first lumen and the second lumen’ and ‘changing a distance between the second lumen and the fillable volume’ fail to specify between which reference points/axes the recited ‘distance’ is being measured (e.g. nearest points along the center line axes, centroids. nearest exterior boundary points, distal endpoints).
For instance, ‘lumens’ and ‘fillable volumes’ (e.g. balloons) are three-dimensional, flexible, and in some cases expandable structures. In the context of three-dimensional movements within an organ—such as rotation, bending, or inflation—one portion of a first body may move closer to a portion of a second body, while another portion of the first body remains static or moves farther away from the same portion of the second body. Because the claim provides no standard or reference metric for measuring distance between these three-dimensional bodies, a POSITA would be unable to determine with reasonable certainty whether such spatial movements constitute ‘changing a distance’ under the claim. Therefore, the claim is indefinite.
Further, regarding claims 45, 75 and 80, the claims are indefinite since the limitation “forming a bend in the second lumen such that an apex of the bend is adjacent the fillable volume within the second organ” utilizes the term of degree/relation “adjacent without providing an objective metric or standard for determining claim scope.”
For instance, it is unclear whether the limitation ‘adjacent’ requires physical contact/touching between the apex of the ‘second lumen’ and the ‘fillable volume’, or whether if merely necessitates spatial proximity without contact. If physical contact is not required, the claim provides no distance threshold or boundary to inform one of ordinary skill in the art how close the apex must be to the fillable volume to fall within the scope of the claim. Further, because the claim fails to define and type of structural connection between the ‘second lumen’ and the ‘fillable volume’, these components are free to shift independently within the three-dimensional space of the organ. As a result, a POSITA would be unable to determine with reasonable certainty when the spatial relationship of ‘adjacent’ is achieved during operation.
Further regarding claims 45, 75 and 80, the claims are indefinite since the directional limitations ‘fillable volume proximal end’ and ‘fillable volume distal end’ lack a defined structural frame of reference.
In medical device claims, ‘proximal’ and ‘distal’ are relative terms that derive their meaning from an established longitudinal axis (typically relative to the operator/insertion axis of the catheter body). Here, while the preamble references ‘a catheter,’ the body of the claim recites a ‘fillable volume’ without defining its structural attachment, orientation, or mounting relationship to the catheter or lumens.
Without a recited structural linkage to the catheter shaft or specified anatomical axis, the fillable volume lacks an established directional orientation. Consequentially, a POSITA would not be able to determine with reasonable certainty which portion of the fillable volume constitutes the ‘proximal end’ versus the ‘distal end’, particularly when deployed or re-oriented within the three-dimensional cavity of an organ.
Further, regarding claims 45, 75 and 80, the claims are indefinite because the step requiring “changing the temperature of the first organ by passing the fluid through the first lumen in the second organ” fails to distinctly define the structural or functional relationship required to effectuate the temperature change.
Specifically, the claim recites passing fluid through a lumen situated within a second organ to alter the temperature of a distinct first organ. However, the claim recites no structural coupling, spatial contact, conductive pathway, or fluid communication between the first lumen in the second organ and the targeted first organ.
Absent any structural or physical linkage defining how fluid passing inside the second organ acts upon the separate first organ, a POSITA cannot determine with reasonable certainty the physical boundaries of the step or what specific spatial configurations would fall within or outside scope of the claimed method.
Further, regarding claims 45, 75 and 80, the claims are indefinite because the term “fillable volume” fails to recite physical structure, rendering the boundaries of the claimed component and associated method steps ambiguous.
Specifically, “volume” refers to a spatial dimension rather than a physical structure. The modifier “fillable” describes a functional property common to any hollow space, including the “first lumen” and “second lumen” already recited in the claim. In a broad sense the limitation ‘fillable volume’ could be construed to encompass space itself. Further, the claim fails to define any physical boundary, membrane, wall, or structure (such as a balloon or chamber) that defines or encloses the volume.
Because “fillable volume” lacks structural bounds, a POSITA cannot determine what physical structure constitutes the claimed “fillable volume,” nor how the method steps related to the “fillable volume”—such as “insertion a fillable volume” or “changing a distance between the second lumen and the fillable volume”—are to be structurally performed relative to an abstract spatial region.
Regarding claim 46, the claim is further indefinite for similar reasons to those outlined above. For instance, the claim recites a ‘a distal terminal end of the first lumen’ and ‘a distal terminal end of the second lumen’. However, as explained above relative to the “fillable space”, it is unclear what end of the lumens would be regarded as ‘distal terminal ends’ for lumens that lack defined structural attachment to the recited catheter system and an implicit axis which extends proximally towards an operator end and distally towards an insertion end.
Regarding claim 47, the claim is further indefinite for similar reasons to those outlined above. For instance, the claim recites “changing the temperature of the first organ by passing the fluid through the fillable volume in the second organ”, however, the claim recites no structural coupling, spatial contact, conductive pathway, or fluid communication between the fillable volume in the second organ and the targeted first organ.
Absent any structural or physical linkage defining how fluid passing inside the second organ acts upon the separate first organ, a POSITA cannot determine with reasonable certainty the physical boundaries of the step or what specific spatial configurations would fall within or outside scope of the claimed method.
Regarding claims 47-51, the claim further limits the ‘changing distance’ limitations by specifying the distances are increased/decreased. However, as previously discussed in more detail with respect to claims 45, 75 and 80 the limitation is indefinite since the claims provide no standard or metric for how these distances are measured. For instance, as discussed above, depending on the motion different points on a first three-dimensional body could simultaneously increase, decrease or remain static relative to a point on a second three-dimensional body. Therefore, for a given motion, without specifying a metric for how the distance is being measured, it could be ambiguous whether a first three-dimensional body is increasing or decreasing in distance from a second three-dimensional body.
Regarding claims 52, 54, 56, 58, the claim further limits the ‘changing distance’ limitations by specifying that the first lumen/second lumen is moved away from/towards the first organ. The claims are indefinite for similar reasons as those outlined above related to ambiguity of how to measure distance with respect to complex movements of bodies in three-dimensional space. Moving a body towards or away from the first organ implies a change of distance between the body and the first organ. However, as discussed above an inherent ambiguity exists for how to measure distance between three-dimensional bodies since movement can cause some aspect of a bodies to move closer together while other aspects of the same bodies remain static relative to each other and others increase in distance. Therefore, without specifying how the distance is measured a POSITA would be unable to determine when a body moves towards or away from an organ in certain instances.
Regarding claims 61, 75 and 80, the claims are indefinite because they fail to specify the physical relationship between the second organ, the third organ and the second lumen. For instance, the claims further recite “inserting/positioning the second lumen into the third organ”. However, the claims previously recite that the second lumen is inserted/positioned into the second organ. Without clearly defining the physical relationships between the second lumen, the second organ and third organ, it is not clear whether second lumen is still within the second organ and what spatial configuration between the second lumen, second organ and third organ is being claimed.
Regarding claim 63-64, the claims further limit the ‘changing distance’ limitation by specifying that it entails increasing/decreasing ‘distance between the first lumen and the third lumen’. However, as previously discussed, the ‘change in distance’ limitations are ill-defined and therefore indefinite.
Regarding claim 65, the claim is indefinite for various reasons.
Firstly, the claim is indefinite since it recites a structural component, i.e. a ‘retainer’, using functional terminology which is so broad that it virtually renders the scope of the recited structure unconfined. For instance, a ‘retainer’ implies a structure that has some ‘retaining’ capability. The claim, however, completely fails to specify what the ‘retainer’ retains or how this retention relates to previously recited method steps, structural components or intended functions of the device. Therefore, the recited ‘retainer’ is a virtually unconfined term, which could be construed to represent a wide variety of disparate structures. To illustrate this ambiguity, one must simply consider that each of the other recited components could be considered a ‘retainer’ under the broadest reasonable interpretation of the term. For instance, each one of the catheter, lumen, or fillable space has the capability of retaining fluid, and therefore could be considered a retainer. Therefore, considering the complete open-ended nature of this limitation a POSITA would be unable to determine with reasonable certainty what structural components would or would not be considered a ‘retainer’ under the broadest reasonable interpretation of the term, rendering the scope of the claim indefinite.
Secondly, the claim is indefinite since it recites a structural component (i.e. ‘a retainer’) of a device but does not recite any structural linkage between the retainer and any other previously recited structural component of the catheter system, instead presenting it as a disembodied physical element.
It is therefore unclear whether the recited retainer represents a sub-component of a larger structure which may or may not comprise the first and second lumens and fillable volume, or whether it represents a separate, unattached component. It is further unclear whether the retainer is a subcomponent of the ‘catheter’ recited in the preamble or whether it represents an element which is distinct from the claimed catheter.
Finally, the claim is indefinite since it recites ‘withdrawing’ the retainer but never recites inserting the same retainer. Therefore, a POSITA would not understand when and how the retainer entered into the second organ or stomach.
Regarding claim 66, the claim recites that before the ‘withdrawing’ step the ‘fillable volume has a first shape’ and after the ‘withdrawing’ step, the ‘fillable volume has a second shape different than the first shape’.
The claim is ambiguous since it fails to explicitly specify the relationship between ‘withdrawing’ step and the change of shape of the ‘fillable volume’. For instance, it is unclear whether applicant is reciting a scenario in which the change of shape is caused by the ‘withdrawing’ step or if applicant’s claim also encompasses a change of shape which incidentally occurs after the ‘withdrawing’ step. If applicant is reciting the former, then it is unclear how the ‘withdrawing’ step results in this change of shape since the claim fail to specify any type of functional or structural relationship between the ‘retainer’ and the ‘fillable volume’. If applicant is reciting latter, the claim is unclear since the claim fails to specify any type of structural components or method steps which would result in this recited change of shape. Therefore, the claim is indefinite since it fails to particularly point out the structural mechanism and method steps which result in this recited change of shape.
Regarding claims 78-79 and 82, the claims are indefinite for similar reasons as those outlined above related to the inherent ambiguity related to determining whether the first lumen and the second lumen are closer or farther from each other in the first and second deployed configurations. The determination of whether these elements are either ‘closer’ or ‘farther’ is inherently dependent on a distance measurement between the two elements. However, as previously discussed in more detail above, applicant has failed to specify how such a distance would be measured which renders the claims indefinite.
In addition, it is unclear what applicant intends by the limitation ‘deployed’. For instance, it is unclear whether the different lumens are ‘deployed’ simply by virtue of being located within the second organ/stomach or if the limitation of ‘deployed’ implies and additional unspecified deployment state.
Finally, the claims are indefinite since ‘first deployed configuration’ and ‘second deployed configuration’ are circularly defined relative to each other rather than by an objective definitional standard. For instance, imagine a ‘first deployment state’ consisting of a first relative distance between the first and second lumens and a ‘second deployment state’ consisting of a second relative distance between the first and second lumens. Now, for the sake of argument imagine a ‘third deployment state’ consisting of a third relative distance between the first and second lumens. If we compare the second relative distance to the third relative distance it possible that the ‘second deployed configuration’ could be considered the ‘first deployed configuration’ relative to the ‘third deployed configuration’. This is because the different deployment configurations are not defined based on an objective metric or standard but rather only circularly relative to each other. Therefore, a POSITA cannot determine whether the first and second lumens are in a first deployment state without knowledge of the second deployment state, and also cannot determine whether the first and second lumens are in the second deployment state without knowledge of the first deployment state. Therefore, a POSITA would be unable to determine for any given deployment state whether the deployment state represents a first or second deployment state, rendering the claim indefinite.
Response to Arguments
Applicant's arguments filed 2/5/26, with respect to the rejection of the claims under 35 U.S.C. 112(a) have been fully considered but they are not persuasive. Applicant cites pars. 57-60 and figs. 9-10 as providing support for the claims rejected under 35 U.S.C. 112(a). Applicant, however, fails to provide any arguments explaining how these paragraphs and figures specifically provide the alleged support. Upon review, the examiner disagrees and maintains the rejection.
Applicant's arguments filed 2/5/26, with respect to the rejection of the claims under 35 U.S.C. 112(b) have been fully considered but they are not persuasive. Applicant does not provide any substantive arguments related to the examiner’s rejection beyond conclusory statements and mischaracterizations of the previous rejection.
For instance, applicant traverses the rejection of claims 45, 75 and 80 simply by stating that the ‘changing distance’ limitations would be clear form pars. 57-60 and figs. 9-10 without providing any additional explanation addressing the rejection and linking it to the provided citation.
With respect to the rejection based on the argument that the recited distances are ill-defined, applicant responded by arguing that the “claims do not have a limitation to distance being ‘measured’”.
The rejection, however, never asserts that the method itself requires a ‘measuring’ step, but rather argues that an ambiguity exists as to how the claim is defining the claimed distances. Therefore, the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights