Prosecution Insights
Last updated: April 19, 2026
Application No. 18/038,013

Delivery Device and Delivery System

Non-Final OA §102§112
Filed
May 20, 2023
Examiner
PELLEGRINO, BRIAN E
Art Unit
3799
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Shenzhen Lifevalve Medical Scientific Co. Ltd.
OA Round
1 (Non-Final)
55%
Grant Probability
Moderate
1-2
OA Rounds
5y 0m
To Grant
91%
With Interview

Examiner Intelligence

Grants 55% of resolved cases
55%
Career Allow Rate
358 granted / 649 resolved
-14.8% vs TC avg
Strong +36% interview lift
Without
With
+35.5%
Interview Lift
resolved cases with interview
Typical timeline
5y 0m
Avg Prosecution
52 currently pending
Career history
701
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
42.7%
+2.7% vs TC avg
§102
23.1%
-16.9% vs TC avg
§112
25.6%
-14.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 649 resolved cases

Office Action

§102 §112
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 . Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. 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 1-10 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. The term “close” in claims 1, 3, 4 is a relative term which renders the claims indefinite. The term “close” 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. It is impossible to discern with any precision to know what arrangement or location is for the “moving assembly” since the claim(s) fail to detail any relationship or positioning of the moving assembly relative to the fixed assembly thus it is not evident if they lie along the same axis or one component is circumscribing the other. Further “close” defines no particular distance whatsoever. Additionally the same is true for the features of the receiving portion being “close” to a stop position is ambiguous when regions are used to define features, such as a distal end portion or proximal end portion. Also the same issue arises with the moving member being “close” to the elastic member but not clear as to what distance or exactly arrangement they are relative to one another. Claim 10 recites the limitations "the first limiting member" and "the second limiting member" in lines 1,2 of claim. In addition claim 10 recites the limitation "the distal end" in line 3 of claim, which is not evident which distal end is being referred to since multiple components were recited to have a distal end. There is insufficient antecedent basis for these limitations in the claim. Dependent claims carry the same indefinite issue of the claim depend on. Claim Rejections - 35 USC § 102 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) 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (CN 109700572). Fig. 1 shows a delivery device 100, comprising a catheter assembly 6 and a control mechanism 7, wherein the catheter assembly comprises an outer sheath catheter 2 and a sheath core 4; the control mechanism controls the sheath catheter to move; a TIP head 5 is arranged at a distal end of the sheath core; the control mechanism comprises a fixed assembly 6 and a moving assembly 7; the moving assembly is arranged close to a proximal end of the fixed assembly; a proximal end portion of the sheath catheter passes through the fixed assembly and then is connected with the inner wall of the sliding handle 7 of the moving assembly through a connecting piece 12. It can be understood that when the sliding handle of the moving assembly moves in the axial direction of the guide rod toward or away from the fixed handle 6, this controls the sheath catheter as distal sheath 2 is configured to move relative to the fixed assembly and either approaches or moves away from the proximal end of the tip 5. The sheath 2 is a part that is sleeved around the outer edge of the push rod 3 and can slide axially relative to the push rod 3. When the end surface of a distal end of the sheath 2 abuts against the end surface of a proximal end of the TIP head 5. Thus the end surface of a distal end of the moving assembly such as the push rod 3 cooperate with the sheath 2 and core 4 to form a space and separate from the end surface of the proximal end of the fixed assembly for accommodating the stent. Regarding claim 2, a proximal end portion of the fixed assembly 6 defining a handle or gripping structure that is hollow just as the sheath 2 comprises a receiving portion with an opening facing the proximal end, and the receiving portion is configured to receive a distal end portion of the moving assembly; or a distal end portion of the moving assembly comprises a receiving portion with an opening facing the distal end, and the receiving portion is configured to receive the proximal end portion of the fixed assembly, see paragraph 80 of translation. Regarding claim 3, it can be construed the outer surface of the distal end portion of the moving assembly has a stop position arranged on the outer surface or a stop on the outer surface of the proximal end portion of the fixed assembly, see paragraphs 49, 81 of translation, such that when an end surface of the receiving portion close to the stop position abuts against the stop position, the moving assembly does not axially move relative to the fixed assembly. Regarding claim 4, Wang also disclose (paragraph 56 of translation) the moving assembly comprises an elastic member and a moving member; the proximal end of the fixed assembly comprises a receiving portion with an opening facing the proximal end or the distal end of the moving assembly comprises a receiving portion with an opening facing the distal end; the elastic member is arranged in an inner cavity of the receiving portion; the moving member is arranged close to the elastic member; and the moving member is at least partially received in the receiving portion and is movably connected with the receiving portion, so that the elastic member is compressed. Regarding claim 5, it can be construed that a first limiting member is arranged on an inner wall of the receiving portion; a second limiting member is arranged on the moving member; and when the first limiting member and the second limiting member are in contact, the moving member is restrained from being away from the receiving portion, see paragraph 81 of translation. With respect to claim 6, Wang also discloses (paragraph 56 of translation) the moving member is configured to move towards a bottom surface of the inner cavity of the receiving portion, compress the elastic member, and separate the first limiting member from the second limiting member. Regarding claim 7, Wang discloses (paragraphs 9,49 of translation) an implant, wherein the implant is configured to be loaded in the outer sheath catheter. With respect to claim 8, Fig. 3 shows the implant is loaded 200 into the outer sheath catheter 2, the end surface of the distal end of the outer sheath catheter abuts against the end surface of the proximal end of the TIP head (see Fig. 2), and the distance between the end surface of the distal end of the moving assembly and the end surface of the proximal end of the fixed assembly is shorter than the distance between the end surface of the distal end of the moving assembly and the end surface of the proximal end of the fixed assembly before the implant is loaded. When the sliding handle 7 moves toward or away from the fixed handle 6 along the axial direction of the guide rod, the distal end of the sheath 2 approaches or moves away from the proximal end of the end 5. When the distal end of the sheath 2 abuts the proximal end of the tip 5, the accommodating chamber is closed and the stent 200 is accommodated in the accommodating chamber; After the implant of the present application is loaded into the outer sheath, the distal end face of the outer sheath abuts the proximal end face of the TIP head; On this basis, a person skilled in the art can expect that the distance between the distal end face of the movable assembly and the proximal end face of the fixation assembly after stent 200 is received in the receiving cavity is shorter than the distance between the distal end face of the movable assembly and the proximal end face of the fixation assembly before loading the implant. Regarding claim 9, it can be seen (Fig. 14) the sliding handle 7 is sleeved on the guide rod 8, thus the sliding handle 7 can move axially along the guide rod 8 relative to the fixed handle 6 and therefore one can construe this as providing a movable track (path) for the operating portion of the moving assembly. Further Wang discloses (paragraph 80 of translation) the moving track passes through the inner cavity of the operating portion; and the operating portion is configured to axially move along the moving track relative to the fixed assembly. Regarding claim 10, as best understood Fig. 8 shows limiting members and the operating portion 3 is configured to further move towards the distal end. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Melsheimer et al. (8585019) teaches a delivery device with a catheter having an outer sheath and an inner sheath core along with a tip head arranged at a distal end of the sheath core. The delivery device also has a control mechanism that has a fixed assembly and a moving assembly. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F. 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, Thomas Barrett can be reached at 571-272-4746. 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. /BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
Read full office action

Prosecution Timeline

May 20, 2023
Application Filed
Jan 10, 2026
Non-Final Rejection — §102, §112 (current)

Precedent Cases

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2y 5m to grant Granted Mar 03, 2026
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
55%
Grant Probability
91%
With Interview (+35.5%)
5y 0m
Median Time to Grant
Low
PTA Risk
Based on 649 resolved cases by this examiner. Grant probability derived from career allow rate.

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