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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I and Species B in the reply filed on August 21, 2026 is acknowledged.
Claims 6 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group (claim 20) and species (claim 6), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 21, 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-12 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.
Claim 7 recites the limitation "the thinnest profile" in Line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites ‘a plurality of indentations’ and is dependent back to claim 4 which recites ‘at least one indentation’ making it unclear if the recitations are meant to refer to the same elements or not.
Claim 9 recites ‘a first indentation’ and ‘a second indentation’ and is dependent back to claim 4 which recites ‘at least one indentation’ making it unclear if the recitations in claim 9 are meant to be part of the recitation in claim 4 or not.
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) 1-5, 7-13, and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imran (US Patent No. 5357979) in view of Hirshman (US 2008/0077049).
Regarding claim 1, Imran teaches a medical device (Abstract) comprising:
a handle (101) including:
a handle body (at least 106), and
an actuator (Column 5, Lines 33-50); and
a shaft extending distally from the handle body (11; Figure 7),
wherein the shaft comprises of a shape memory material (Column 2, Lines 24-26).
Imran teaches a shaft with different austenitic states (Abstract) but is silent explicitly on the claimed sections having differing austenitic finish temperatures.
Hirshman teaches a medical device (Abstract) comprising:
a shaft (21)
wherein the shaft comprises of a shape memory material (Paragraph 0027: “The shaft, and in particular the tubular member, can comprise one or more materials that exhibit shape memory or superelastic behavior, or both. These materials can be metal alloys, for example Nitinol”; Paragraph 0028), wherein the shaft includes a proximal section and a distal section (Figure 5; Paragraph 0047; “a shaft 10 with a proximal end 12 and distal end 11”), the proximal section having a first austenitic finish temperature and the distal section having a second austenitic finish temperature (Paragraph 0004; “The alloy in each zone can have a temperature, A.sub.f, above which the tubular member may assume the austenitic state. One zone of the tubular member can have one A.sub.f, and a second zone can have a second, higher A.sub.f.“), and
wherein the first austenitic finish temperature is lower than the second austenitic finish temperature (Paragraph 0004; “The initial A.sub.f can be below the temperature of use and the second A.sub.f temperature can be above the temperature of use.”).
It would have been obvious to one of ordinary skill in the art to have modified Imran with Hirshman because it allows for the desired flexibility that one of ordinary skill in the art could achieve through routine experimentation of conventionally used shape-memory materials.
Regarding claim 2, Imran teaches a shaft with different austenitic states (Abstract) but is silent explicitly on the claimed sections having differing austenitic finish temperatures.
Hirshman teaches wherein the shaft further includes a transition section between the proximal section and the distal section, wherein the transition section includes a proximal portion having an austenitic finish temperature approximate to or greater than the first austenitic finish temperature, and wherein the transition section further includes a distal portion having an austenitic finish temperature approximate to or less than second austenitic finish temperature (Paragraph 0045-0046; arbitrarily defining what is considered a transition section as including parts of both the proximal section and distal sections of 21 of Hirshman would thus meet this design). It would have been obvious to one of ordinary skill in the art to have modified Imran with Hirshman because it allows for the desired flexibility that one of ordinary skill in the art could achieve through routine experimentation of conventionally used shape-memory materials.
Regarding claim 3, Imran teaches a shaft with different austenitic states (Abstract) but is silent explicitly on the claimed sections having differing austenitic finish temperatures.
Hirshman teaches wherein the first austenitic finish temperature is less than or equal to body temperature, and wherein the second austenitic finish temperature is greater than body temperature (Paragraph 0004: “The initial A.sub.f can be below the temperature of use and the second A.sub.f temperature can be above the temperature of use. For example, the temperature of use can be the normal body temperature of a human body, or 37.degree. C., or it can be higher than body temperature, such as 42.degree. C.”). It would have been obvious to one of ordinary skill in the art to have modified Imran with Hirshman because it allows for the desired flexibility that one of ordinary skill in the art could achieve through routine experimentation of conventionally used shape-memory materials.
Regarding claim 4, Irman is silent on the indentations. Hirshman teaches wherein the distal section includes at least one indentation (Paragraph 0063 and 0071-0076). It would have been obvious to one of ordinary skill in the art to have modified Imran with Hirshman because it allows for the desired flexibility that one of ordinary skill in the art could achieve through routine experimentation of conventionally used shape-memory materials.
Regarding claim 5, Irman is silent on the indentations. Hirshman teaches wherein the at least one indentation is a concave cut, and the at least one indentation spans at least a portion of a circumference of the distal section (Paragraphs 0072-0073). Hirshman teaches the shape of the indentations as being a design choice (Paragraphs 0072-0073) and therefore it would have been obvious to one of ordinary skill in the art to have modified Irman in view of Hirshman such that wherein the at least one indentation is a concave cut, and the at least one indentation spans at least a portion of a circumference of the distal section because Hirshman teaches these characteristics as being a design choice and thus one of ordinary skill in the art could through routine experimentation have these characteristics as desired. Furthermore, the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Regarding claim 7, Irman is silent on the indentations. Hirshman teaches the bendable portion and varying circumferences as being a design choice (Paragraphs 0064-0065) and therefore it would have been obvious to one of ordinary skill in the art to have modified Irman in view of Hirshman such that wherein the distal section includes a bendable portion, wherein the bendable portion is of a lesser circumference than a circumference of a remaining portion of the distal section, and wherein the bendable portion is a portion of the distal section having the thinnest profile because Hirshman teaches these characteristics as being a design choice and thus one of ordinary skill in the art could through routine experimentation have these characteristics as desired.
Regarding claim 8, Irman is silent on the indentations. Hirshman teaches wherein the distal section includes a plurality of indentations (Paragraph 0063 and 0071-0076). It would have been obvious to one of ordinary skill in the art to have modified Imran with Hirshman because it allows for the desired flexibility that one of ordinary skill in the art could achieve through routine experimentation of conventionally used shape-memory materials.
Regarding claim 9, Irman is silent on the indentations. Hirshman teaches wherein the distal section includes a first indentation and a second indentation (Paragraph 0063 and 0071-0076). It would have been obvious to one of ordinary skill in the art to have modified Imran with Hirshman because it allows for the desired flexibility that one of ordinary skill in the art could achieve through routine experimentation of conventionally used shape-memory materials.
Regarding claim 10, Irman is silent on the indentations. Hirshman teaches the shape and bending profiles as being a design choice (Paragraphs 0072-0073) and therefore it would have been obvious to one of ordinary skill in the art to have modified Irman in view of Hirshman such that wherein the first indentation and the second indentation are of different shapes, and a bending profile of the first indentation is different from a bending profile of the second indentation because Hirshman teaches these characteristics as being a design choice and thus one of ordinary skill in the art could through routine experimentation have these characteristics as desired.
Regarding claim 11, Irman is silent on the indentations. Hirshman teaches wherein the first indentation is a concave cut (Paragraphs 0071-0073) and that the indentations can varying in shape to achieve desired characteristics and thus is a design choice (Paragraph 0072) and therefore it would have been obvious to one of ordinary skill in the art to have modified Irman in view of Hirshman such that and the second indentation is a V-shaped cut because Hirshman teaches these characteristics as being a design choice and thus one of ordinary skill in the art could through routine experimentation have these characteristics as desired. Furthermore, the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Regarding claim 12, Irman is silent on the indentations. Hirshman teaches the shape and size of the indentations can vary as desired to achieve desired characteristics (Paragraph 0072) and therefore it would have been obvious to one of ordinary skill in the art to have modified Irman in view of Hirshman such that wherein each of the first indentation and the second indentation spans a circumference of the distal section between approximately 20° and approximately 170° because Hirshman teaches these characteristics as being a design choice and thus one of ordinary skill in the art could through routine experimentation have these characteristics as desired.
Regarding claim 13, Irman is silent on the indentations. Hirshman teaches wherein the at least one indentation is laser cut (Paragraph 0071). It would have been obvious to one of ordinary skill in the art to have modified Imran with Hirshman because it allows for the desired flexibility that one of ordinary skill in the art could achieve through routine experimentation of conventionally used shape-memory materials.
Regarding claim 15, Imran teaches a shaft with different austenitic states (Abstract) but is silent explicitly on the claimed sections having differing austenitic finish temperatures.
Hirshman teaches wherein both the first austenitic finish temperature and the second austenitic finish temperature are set via heat treatment of the proximal section and the distal section of the shaft (Paragraphs 0041 and 0104). It would have been obvious to one of ordinary skill in the art to have modified Imran with Hirshman because it allows for the desired flexibility that one of ordinary skill in the art could achieve through routine experimentation of conventionally used shape-memory materials.
Regarding claim 16, Irman teaches a medical device (Abstract) comprising:
a shaft (11; Figure 7) extending distally from a handle body (at least 106 of 101), wherein the shaft comprises of a shape memory material (Column 2, Lines 24-26),
Imran teaches a shaft with different austenitic states (Abstract) but is silent explicitly on the claimed sections having differing austenitic finish temperatures.
Hirshman teaches a medical device (Abstract) comprising:
a shaft (21), wherein the shaft comprises of a shape memory material (Paragraph 0027: “The shaft, and in particular the tubular member, can comprise one or more materials that exhibit shape memory or superelastic behavior, or both. These materials can be metal alloys, for example Nitinol”; Paragraph 0028),
wherein the shaft includes a proximal section and a distal section (Figure 5; Paragraph 0047; “a shaft 10 with a proximal end 12 and distal end 11”), the proximal section having a first austenitic finish temperature and the distal section having a second austenitic finish temperature (Paragraph 0004; “The alloy in each zone can have a temperature, A.sub.f, above which the tubular member may assume the austenitic state. One zone of the tubular member can have one A.sub.f, and a second zone can have a second, higher A.sub.f.“),
wherein the first austenitic finish temperature is lower than the second austenitic finish temperature (Paragraph 0004; “The initial A.sub.f can be below the temperature of use and the second A.sub.f temperature can be above the temperature of use.”)., and
Irman is silent on the indentations.
Hirshman teaches the shape and size of the indentations can vary as desired to achieve desired characteristics such as flexibility which would change bending profiles (Paragraphs 0072-0073) and therefore it would have been obvious to one of ordinary skill in the art to have modified Irman in view of Hirshman such that wherein the distal section includes a first indentation defining a first bending profile and a second indentation defining a second bending profile, wherein the first bending profile is different from the second bending profile because Hirshman teaches these characteristics as being a design choice and thus one of ordinary skill in the art could through routine experimentation have these characteristics as desired.
It would have been obvious to one of ordinary skill in the art to have modified Imran with Hirshman because it allows for the desired flexibility that one of ordinary skill in the art could achieve through routine experimentation of conventionally used shape-memory materials.
Regarding claim 17, Irman is silent on the indentations. Hirshman teaches the shape and size of the indentations can vary as desired to achieve desired characteristics (Paragraph 0072) and therefore it would have been obvious to one of ordinary skill in the art to have modified Irman in view of Hirshman such that wherein the first bending profile is a U-shaped bend, and wherein the second bending profile is a V-shaped bend because Hirshman teaches these characteristics as being a design choice and thus one of ordinary skill in the art could through routine experimentation have these characteristics as desired. Furthermore, the changes in shape claimed represent a design choice, and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Regarding claim 18, Irman is silent on the indentations. Hirshman teaches the shape and size of the indentations can vary as desired to achieve desired characteristics (Paragraph 0072) and therefore it would have been obvious to one of ordinary skill in the art to have modified Irman in view of Hirshman such that wherein each of the first indentation and the second indentation spans a circumference of the distal section between approximately 20° and approximately 170° because Hirshman teaches these characteristics as being a design choice and thus one of ordinary skill in the art could through routine experimentation have these characteristics as desired.
Regarding claim 19, Imran teaches a shaft with different austenitic states (Abstract) but is silent explicitly on the claimed sections having differing austenitic finish temperatures. Hirshman teaches wherein the first austenitic finish temperature is less than or equal to body temperature, and wherein the second austenitic finish temperature is greater than body temperature (Paragraph 0004: “The initial A.sub.f can be below the temperature of use and the second A.sub.f temperature can be above the temperature of use. For example, the temperature of use can be the normal body temperature of a human body, or 37.degree. C., or it can be higher than body temperature, such as 42.degree. C.”). It would have been obvious to one of ordinary skill in the art to have modified Imran with Hirshman because it allows for the desired flexibility that one of ordinary skill in the art could achieve through routine experimentation of conventionally used shape-memory materials.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imran (US Patent No. 5357979) in view of Hirshman (US 2008/0077049) in further view of Tutungi et al. (US 2017/0165456).
Regarding claim 14, Irman is silent on the plurality of steering elements. Tutungi teaches further comprising a plurality of steering elements, wherein each of the plurality of steering elements extends between the actuator and the distal section through an internal portion of the shaft (Paragraphs 0011-0013 and 0044-0045). It would have been obvious to one of ordinary skill in the art to have modified Irman with Tutungi because it allows for flexibility through various control of axial translation regions individually (Paragraph 0023 of Tutungi).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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