DETAILED ACTION
This action is responsive to the amendment filed 5/1/25.
Claims 45-66 and 75-82 are finally 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 and 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, the claims recite the non-original limitations of:
‘changing the distance between the first lumen and the second lumen […].’
‘changing the distance between the second lumen and the fillable space […]’
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 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 modified 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 and 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 claim recites the limitation ‘fillable space’. It is not clear what is meant by the term ‘fillable space’. This does not appear to be a term of art, neither is it ever used in the specification. Therefore, POSITA would not be apprised to its intended meaning and the limitation is indefinite.
Further regarding claims 45, 75 and 80, the claims recite the limitation ‘forming a bend in the second lumen such that an apex of the bend is adjacent the fillable space’. The examiner notes that the term ‘adjacent’ is a term of degree. The claim provides no objective boundary or definition for what constitutes ‘adjacent’, nor does it explain how proximity is determined. Further, the specification fails to provide examples or guidance, leaving POSITA without clear understanding of the scope of this limitation.
Further, regarding claim 45, 75 and 80, the claims recite the limitations:
‘changing the distance between the first lumen and the second lumen […].’
‘changing the distance between the second lumen and the fillable space […]’
These limitations are unclear since they are purely functional in nature and lack any corresponding structure, materials or method steps that would inform POSITA as to how the claimed changes in distance are implemented or achieved, such that POSITA would not be able to determine with reasonable clarity the bounds of the invention.
Further, regarding claim 45, 75 and 80, it is unclear from the claims how the distance between the first and second lumen and the distance between the second lumen and the fillable space is being measured.
Response to Arguments
Applicant's arguments filed 5/1/25 with respect to the rejection of the claims under 35 U.S.C. 112, first paragraph, have been fully considered but they are not persuasive. The examiner disagrees that pars. 57-60 and figs. 9-10, provide sufficient support for the limitations in question. Therefore, the rejection is maintained.
Conclusion
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 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
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