Prosecution Insights
Last updated: April 19, 2026
Application No. 18/563,951

SURGICAL DEVICES USING MULTIPLE MEMORY SHAPE MEMORY MATERIALS

Non-Final OA §102§103
Filed
Nov 24, 2023
Examiner
LABRANCHE, BROOKE N
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Smarter Alloys Inc.
OA Round
1 (Non-Final)
73%
Grant Probability
Favorable
1-2
OA Rounds
3y 1m
To Grant
87%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allow Rate
326 granted / 448 resolved
+2.8% vs TC avg
Moderate +15% lift
Without
With
+14.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
72 currently pending
Career history
520
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
45.2%
+5.2% vs TC avg
§102
29.5%
-10.5% vs TC avg
§112
20.7%
-19.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 448 resolved cases

Office Action

§102 §103
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 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 ( 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 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) 1-6, 9, 10, 12, and 18-20 are reje cted under 35 U.S.C. 102(a)(1) as being anticipated by Daly et al. ( "Fabrication of a Novel Monolithic NiTi Based Shape Memory Microgripper via Multiple Memory Material Processing". ASME 2011 Conference on Smart Materials, Adaptive Structures and Intelligent Systems, 7 February 2012, pp. 505-508 ; https://doi.org/10.1115/SMASIS2011-4903). Regarding claim 1, Daly discloses a surgical device comprising (microgripper, abstract) : at least one processed region having altered properties to provide a predetermined functionality (introduction paragraph 2 discloses inducing a localized austenite to martensite phase conversion within a processing region, thus forming Multiple Memory Material) ; wherein the surgical device is made from a shape memory alloy ( Introduction paragraph 1) ); and wherein the SMA is processed via a multiple memory material process to impart the at least one processed region into the SMA (Introduction paragraph 2, see FIG 1 showing 3 different memory regions) . Regarding claim 2, Daly discloses at least two processed regions (FIG 1, Intorduction paragraphs 1-3, and Experimental paragraph 1 show at least 5 processed regions with 3 different memory capabilities) . Regarding claim 3, Daly discloses one of the at least two processed regions provides a functionality at a first predetermined temperature and another of the at least two processed regions provides a functionality at a second predetermined temperature (Fig 2 shows the three different temperatures at which the 1 st , 2 nd , and 3 rd memory are actuated at) . Regarding claim 4, Daly discloses t he first predetermined temperature and the second predetermined temperature are different (FIG 2 shows two different temperatures) . Regarding claim 5, Daly discloses the first predetermined temperature and the second predetermined temperature are the same (FIG 1 shows there can be two regions which both possess the 1 st memory. Therefore, these two regions have a first and second temperature which is the same) . Regarding claim 6, Daly discloses the surgical device is one of a guidewire (FIG 1(a) shows a single wire which is interpreted as being usable as a guidewire) , a catheter, an adjustable diameter ring, a tissue retractor, an annuloplasty band, a heart stabilizer, a clamp (FIG 1(b) microgrippers are interpreted as forming a clamp) , a frame for an embolic filter, a stent, a valve, a clip or a drug delivery device. Regarding claim 9, Daly discloses when the surgical device is a guidewire, the at least one processed region includes at least two processed regions located on a diameter of the guidewire (FIG 1 shows at least the 1 st memory section and 2 nd memory section, which are interpreted as forming two processed regions along the diameter of the wire) . Regarding claim 10, Daly discloses the at least two processed regions are opposite each other (FIG 1(a) show the regions are opposite each other across an axis dividing the middle of the device) . Regarding claim 12, Daly discloses when the surgical device is a clamp, in response to a predetermined temperature (As established in FIG 2) , the at least one processed region bends from an open position to a closed position (Abstract – “actuation and gripping maneuvers are achieved by thermally activating processed material regions which possess unique shape memory transformation temperatures and shape set geometries” . Regarding claim 18, Daly discloses the SMA is a form of a sheet, a wire or a tube (FIG 1(a) shows the NiTi wire) . Regarding claim 19 and 20, Daly discloses the surgical device is post-processed after the SMA is processed via the multiple memory material process wherein post processing comprises cold work, heat treatment, tumbling, thermal cycling, training or electropolishing (Experimental paragraphs 2-4 disclose that after MMM processing, a post processing of heating and cooling is performed, which is interpreted as thermal cycling) . 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. Claim(s) 7, 8, 11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable ov er Daly et al. in view of Kahn (WO 2011/014962). Regarding claim 7, Daly et al. discloses the invention substantially as claimed, as set forth above for claim 6. Daly et al. is silent regarding the surgical device is a catheter, the at least one processed region is near a tip of the catheter whereby when a predetermined temperature is applied to the catheter, the tip of the catheter bends at varying angles. However, Kahn teaches in the same field of endeavor a method of treating a material wherein energy is applied to a predetermined portion of shape memory alloy with a laser (claim 1, 2, 6, 9) to provide a shape memory material having two transformation temperatures (claim 14) and may further be cooled to after processing (claim 18, para. [0073]), wherein multiple transformation temperatures are to be used to "gradually adjust the shape of the object' and 'for gradual opening or closing based on the temperature', where such materials may be used in a tube (interpreted as a catheter, [0116]) the at least one processed region is near a tip of the catheter whereby when a predetermined temperature is applied to the catheter, the tip of the catheter bends at varying angles ([0116] discloses construction of a tube wherein one end can be expanded and contracted, which is interpreted as a tip of the catheter that bends at varying angles) . Kahn further contemplates a variety of surgical device which would be known to apply the material to including a microgripper ([0116]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the surgical device of Daly et al. to be in the form of a tube instead of a microgripper, as taught by Kahn, since Kahn teaches that the use of either instrument is known to be interchangeable in the art for the purpose of forming a particular device which can bend, open, or close as desired by a particular procedure and enabled by the properties of the SMA. Regarding claim 8 , Daly et al. discloses the invention substantially as claimed, as set forth above for claim 6. Daly et al. is silent regarding the surgical device is a catheter, the at least one processed region includes pleats or folds whereby when a predetermined temperature is applied to the catheter, a diameter of the catheter increases to a target diameter. However, Kahn teaches in the same field of endeavor a method of treating a material wherein energy is applied to a predetermined portion of shape memory alloy with a laser (claim 1, 2, 6, 9) to provide a shape memory material having two transformation temperatures (claim 14) and may further be cooled to after processing (claim 18, para. [0073]), wherein multiple transformation temperatures are to be used to "gradually adjust the shape of the object' and 'for gradual opening or closing based on the temperature', where such materials may be used in a tube (interpreted as a catheter, [0116]) the at least one processed region includes pleats or folds whereby when a predetermined temperature is applied to the catheter, a diameter of the catheter increases to a target diameter ([0116] discloses construction of a tube wherein one end can be expanded and contracted, which is interpreted as a tip of the catheter that includes a pleat or fold to achieved the reduced diameter before expanding to the increased target diameter to bond to another tube member) . Kahn further contemplates a variety of surgical device which would be known to apply the material to including a microgripper ([0116]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the surgical device of Daly et al. to be in the form of a tube instead of a microgripper, as taught by Kahn, since Kahn teaches that the use of either instrument is known to be interchangeable in the art for the purpose of forming a particular device which can bend, open, or close as desired by a particular procedure and enabled by the properties of the SMA. Regarding claim 11 , Daly et al. discloses the invention substantially as claimed, as set forth above for claim 6. Daly et al. is silent regarding the surgical device is an adjustable diameter ring, in response to a predetermined temperature, the at least one processed region bends to increase a diameter of the adjustable diameter ring. However, Kahn teaches in the same field of endeavor a method of treating a material wherein energy is applied to a predetermined portion of shape memory alloy with a laser (claim 1, 2, 6, 9) to provide a shape memory material having two transformation temperatures (claim 14) and may further be cooled to after processing (claim 18, para. [0073]), wherein multiple transformation temperatures are to be used to "gradually adjust the shape of the object' and 'for gradual opening or closing based on the temperature', where such materials may be used in an adjustable diameter ring (Valve, [0116]) in response to a predetermined temperature, the at least one processed region bends to increase a diameter of the adjustable diameter ring ( a gradual opening or closing based on the temperature applied to the object , [0116] ). Kahn further contemplates a variety of surgical device which would be known to apply the material to including a microgripper ([0116]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the surgical device of Daly et al. to be in the form of a n adjustable diameter ring instead of a microgripper, as taught by Kahn, since Kahn teaches that the use of either instrument is known to be interchangeable in the art for the purpose of forming a particular device which can bend, open, or close as desired by a particular procedure and enabled by the properties of the SMA. Regarding claim 13 , Daly et al. discloses the invention substantially as claimed, as set forth above for claim 6. Daly et al. is silent regarding the surgical device is a frame for an embolic filter, in response to a predetermined temperature, the at least one processed region bends from an open position to a closed position. However, Kahn teaches in the same field of endeavor a method of treating a material wherein energy is applied to a predetermined portion of shape memory alloy with a laser (claim 1, 2, 6, 9) to provide a shape memory material having two transformation temperatures (claim 14) and may further be cooled to after processing (claim 18, para. [0073]), wherein multiple transformation temperatures are to be used to "gradually adjust the shape of the object' and 'for gradual opening or closing based on the temperature', where such materials may be used in a frame (401, FIG 20, [0118]) for an embolic filter (although shown being used as a frame for a diaphragm, the expandable frame could also support an embolic filter) in response to a predetermined temperature, the at least one processed region bends from an open position to a closed position ( a gradual opening or closing based on the temperature applied to the object , [0116]). Kahn further contemplates a variety of surgical device which would be known to apply the material to including a microgripper ([0116]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the surgical device of Daly et al. to be in the form of a frame instead of a microgripper, as taught by Kahn, since Kahn teaches that the use of either instrument is known to be interchangeable in the art for the purpose of forming a particular device which can bend, open, or close as desired by a particular procedure and enabled by the properties of the SMA. Regarding claim 14-15 , Daly et al. discloses the invention substantially as claimed, as set forth above for claim 6. Daly et al. is silent regarding the surgical device is a stent, the at least one processed region includes multiple processed regions that respond to different predetermined temperatures and wherein when one of the different predetermined temperatures is applied to the stent, a portion of the multiple processed regions expands in response to the application of the different predetermined temperature. However, Kahn teaches in the same field of endeavor a method of treating a material wherein energy is applied to a predetermined portion of shape memory alloy with a laser (claim 1, 2, 6, 9) to provide a shape memory material having two transformation temperatures (claim 14) and may further be cooled to after processing (claim 18, para. [0073]), wherein multiple transformation temperatures are to be used to "gradually adjust the shape of the object' and 'for gradual opening or closing based on the temperature', where such materials may be used in a stent ([0116 and 0131]) t he at least one processed region includes multiple processed regions that respond to different predetermined temperatures and wherein when one of the different predetermined temperatures is applied to the stent, a portion of the multiple processed regions expands in response to the application of the different predetermined temperature ( a gradual opening or closing based on the temperature applied to the object , [0116]). Kahn further contemplates a variety of surgical device which would be known to apply the material to including a microgripper ([0116]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the surgical device of Daly et al. to be in the form of a stent instead of a microgripper, as taught by Kahn, since Kahn teaches that the use of either instrument is known to be interchangeable in the art for the purpose of forming a particular device which can bend, open, or close as desired by a particular procedure and enabled by the properties of the SMA. Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentabl e over Daly et al. in v iew of Sheu et al. (US 7,909,864). Regarding claim 16 , Daly et al. discloses the invention substantially as claimed, as set forth above for claim 6. Daly et al. is silent regarding the surgical device is a drug delivery device that includes a set of micro-pores filled in a pressure condition, in response to a predetermined temperature, the at least one processed region exposes the micro-pores to release a drug stored in the set of micro-pores. However, She u et al. teaches a surgical device in the form of a drug delivery device (314, FIGs 3a-3b show a drug delivery stent) which can be made of a shape memory material (Col 4 lines 51-63) and includes a set of micro-pores filled in a pressure condition (Pores 324, comprising drug 322, col 4 line 64-col 5 line 13) , in response to a predetermined temperature, the at least one processed region exposes the micro-pores to release a drug stored in the set of micro-pores (FIGs 3a-3b show the ballon expansion causing the release of the drug form the pores but col 4 line 64-col 5 line 13 also discloses the material can be a shape memory material, therefore it is possible that the expansion occurs as a response to thermal change). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the surgical device of Daly et al. to be in the form of a drug delivery stent having micro-pores instead of a microgripper, as taught by Sheu, for the purpose of applying the SMA properties taught by Daly et al. to a different type of surgical device commonly known in the art, thereby achieving the predictable result of reliably expanding and contracting the device. In the device as modified, such expansion results int eh release of drug stored within the micro-pores as claimed. Allowable Subject Matter Claim 17 is 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. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT BROOKE N LABRANCHE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9775 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8-5 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Elizabeth Houston can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 5712727134 . 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. /BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

Nov 24, 2023
Application Filed
Feb 26, 2026
Non-Final Rejection — §102, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
73%
Grant Probability
87%
With Interview (+14.6%)
3y 1m
Median Time to Grant
Low
PTA Risk
Based on 448 resolved cases by this examiner. Grant probability derived from career allow rate.

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