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 .
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 8 recites “an expandable outer balloon tightly connected to the liaising structure and encasing the distal end of the liaising structure, the positioning unit.” Which should be amended to “an expandable outer balloon tightly connected to the liaising structure and encasing the distal end of the liaising structure and the positioning unit.”.
Claim 9 recites “wherein at least a tissue contacting face of the expandable outer balloon is made of a material compliant with a tissue forming the wall of the body cavity.” Which should be amended to “wherein at least a tissue contacting face of the expandable outer balloon is made of a material compliant with a tissue, forming the wall of the body cavity.” Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: positioning unit in claim 1 and various dependent claims. The claim does not provide any structure for the positioning unit or what it encompasses. The specification is utilized for meaning of the positioning unit.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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.
Claim 9 is/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. The examiner contends that applicant fails to provide adequate written description for the breadth of the claim. Specifically, the limitation “is made of a material compliant with a tissue forming the wall of the body cavity” in claim 9 is broad enough to encompass any material imaginable.
The term “tightly” in claim 8 is a relative term which renders the claim indefinite. The term “tightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “tightly” in claim 10 is a relative term which renders the claim indefinite. The term “tightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the associated balloon". There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the wall". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-19 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “an elongated liaising structure (2; 29) having a distal end (211; 2119) arrangeable in the body cavity”, “a proximal end arrangeable outside the body while the distal end (211; 2119) is in the body cavity”, etc. The claim should be modified to incorporate “configured to” or similar to avoid positively reciting the human body. Dependent claims 2-19 are rejected for depending on rejected claim 1.
Claim Rejections - 35 USC § 103
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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7, 10, 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200170707 to Eugster et al. (hereinafter “Eugster”) in view of US 20080269559 to Miyamoto et al. (hereinafter “Miyamoto”).
Regarding claim 1.(Currently Amended) Eugster discloses a medical endodevice (abstract, para 0050) for an intervention inside a body cavity of a body of a human or animal being (fig 1), comprising an elongated liaising structure (abstract, para 11, 0050-0051, etc., liasing structure 2) having a distal end arrangeable in the body cavity (fig 1) and a proximal end arrangeable outside the body while the distal end is in the body cavity (fig. 1, para 0011), an intervention tool arranged to manipulate a target tissue inside the human or animal body (para 0013, 0018), wherein the intervention tool is arranged at the distal end (para 0011) of the liaising structure (para 0011), a positioning unit having a moving formation arranged to dislocate the intervention tool relative to the target tissue (para 0014), a decoupling structure arranged to decouple the positioning unit once it is arranged in the body cavity (para 0036),
Eugster discloses having anchoring formation to fix the positing unit to the fixing tissue (para 0017, etc.) but fails to disclose having and at least one expandable member mounted to the positioning unit and being configured to fix the positioning unit in the body cavity when being expanded.
Miyamoto, from a similar field of endeavor teach having balloons that would be expanded after the endoscope is inserted into a body cavity to contact inside the body to enable the distal end portion of the endoscope to be fixed in the body cavity (para 0017, 0079, 0097). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Eugster with the teachings of Miyamoto to provide the predictable result of fixing the endoscope to the body cavity using inflatable balloons.
Regarding claim 2. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 1, wherein the at least one expandable member comprises at least two expandable members (Miyamoto, fig 6, para 0109, etc.).
Regarding claim 3. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 2, wherein two expandable members of the at least two expandable members are arranged at essentially opposite sides of the positioning unit (Miyamoto, fig 6, 8, 12, 15, 18, para 0090 “a first balloon 10 a and a second balloon 10 b disposed so as to oppose to each other”, para 0109, etc.; arbitrary selection of the at least two expandable members).
Regarding claim 4. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 2, wherein two expandable members of the at least two expandable members are arranged at a single side of the positioning unit (Miyamoto, fig. 25, arbitrary selection of the two expandable members).
Regarding claim 5. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 2, wherein the at least two expandable members are individually expandable (Miyamoto, para 0119, 0152 “each of the balloons 10 a to 10 d is individually inflated and contracted”).
Regarding claim 6. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 1, further comprising a spacer element, wherein the spacer element and one of the at least one expandable member are arranged at essentially opposite sides of the positioning unit (it is noted that the claim does not provide any detailed structure of the spacer element, under its BRI, any element that provides the same function would read over the claimed limitation as recited. Here, one of the inflatable balloons are being considered to be the spacer element. Furthermore, KSR “(B) Simple substitution of one known element for another to obtain predictable results;”; Miyamoto, fig 6, 8, 12, 15, 18, para 0090 “a first balloon 10 a and a second balloon 10 b disposed so as to oppose to each other”, para 0109, etc.; arbitrary selection of the at least two expandable members).
Regarding claim 7. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 1, wherein each of the at least one expandable member comprises a balloon and an inflation/deflation structure configured to inflate and deflate the associated balloon (Miyamoto, para 0119, 0152, fig. 1)
Regarding claim 10. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 1, further comprising a laser arrangement, wherein the intervention tool is a laser beam propagating structure of the laser arrangement (7; 70) configured to propagate a laser beam (para 0021-0022, etc.).
Regarding claim 12. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 10, wherein the laser beam propagating structure of the laser arrangement comprises an adjustable optics arranged to direct the laser beam in various directions (para 0022, etc.).
Regarding claim 13. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 10, wherein the laser arrangement comprises an optical fiber connectable to a laser source, the optical fiber has a distal end from which the laser beam is ejectable, and the laser beam propagating structure of the laser arrangement comprises the distal end of the optical fiber of the laser arrangement (para 0024).
Regarding claim 14. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 1, wherein the moving formation of the positioning unit has a first rail, a first slide and a first arm, wherein the first slide is mounted to the first rail such that it is movable along the first rail, and the first arm is at one end region rotatably mounted to the first slide (para 0027).
Regarding claim 15. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodeviceof claim 14, wherein the moving formation of the positioning unit has a further first rail, a further first slide and a further first arm, wherein the further first slide is mounted to the further first rail such that it is movable along the further first rail, and the further first arm is at one end region rotatably mounted to the further first slide (para 0020).
Regarding claim 16. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 1, wherein the at least one expandable member is dimensioned in accordance with the body cavity to fix the positioning unit in the body cavity when being expanded by being pressed against a boundary of the body cavity (Miyamoto, fig. 8).
Regarding claim 17. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 1, comprising a robot arrangement connected to the intervention tool and the positioning unit via the liaising structure (Fig 1).
Regarding claim 18. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 1, wherein the decoupling structure is arranged to recouple the positioning unit after being decoupled (para 0037).
Claim(s) 8-9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eugster as modified by Miyamoto as applied to claims above, and further in view of US 20220125506 to Rzeszutek et al. (hereinafter “Rzeszutek”).
Regarding claim 8. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 1, but fails to disclose comprising an expandable outer balloon tightly connected to the liaising structure and encasing the distal end of the liaising structure, the positioning unit.
Rzeszutek, from a similar field of endeavor teaches having a deployable applicator head to be delivered to a tissue cavity and ablate marginal tissue surrounding the tissue cavity (para 0003) having an expandable configuration (para 0007). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Eugster as modified by Miyamoto with the teachings of Rzeszutek to provide the predictable result of ablating marginal tissue surrounding the tissue cavity.
Regarding claim 9. (Currently Amended) Eugster as modified by Miyamoto and Rzeszutek renders obvious the medical endodevice of claim 8, wherein at least a tissue contacting face of the expandable outer balloon is made of a material compliant with a tissue forming the wall of the body cavity (Eugster para 0033).
Regarding claim 19. (New) Eugster as modified by Miyamoto and Rzeszutek renders obvious the medical endodevice of claim 8, wherein the expandable outer balloon encases the at least one expandable member (Rzeszutek, para 0008).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eugster as modified by Miyamoto as applied to claims above, and further in view of US 20110082450 to Melsky et al. (hereinafter “Melsky”).
Regarding claim 11. (Currently Amended) Eugster as modified by Miyamoto renders obvious the medical endodevice of claim 10, but fails to disclose further comprising an expandable outer balloon tightly connected to the liaising structure and encasing the distal end of the liaising structure and the positioning unit,
Rzeszutek, from a similar field of endeavor teaches having a deployable applicator head to be delivered to a tissue cavity and ablate marginal tissue surrounding the tissue cavity (para 0003) having an expandable configuration (para 0007). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Eugster as modified by Miyamoto with the teachings of Rzeszutek to provide the predictable result of ablating marginal tissue surrounding the tissue cavity.
Eugster as modified by Miyamoto and Rzeszutek renders obvious the limitations above but fails to disclose wherein the expandable outer balloon is at least partially transparent to the laser beam propagated by the laser beam propagating structure (71; 710) of the laser arrangement (7; 70).
Melsky, from a similar field of endeavor teaches that the projection balloon to be substantially transparent to the radial energy at the selected wavelength to provide a low-loss transmission pathway from the ablation element 40 to the target (para 0053). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of Eugster as modified by Miyamoto and Rzeszutek with the teachings of Melsky to provide the predictable result of providing a low-loss transmission pathway from the ablation element to the target.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796
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