Prosecution Insights
Last updated: August 15, 2026
Application No. 18/758,424

ENCLOSURE FOR MITIGATION OF LEAKAGE BY SYRINGE ASSEMBLY

Non-Final OA §102§103§112
Filed
Jun 28, 2024
Priority
Jun 11, 2024 — CIP of 18/740,352
Examiner
STRANSKY, KATRINA MARIE
Art Unit
Tech Center
Assignee
Merck Sharp & Dohme LLC
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
1y 0m
Est. Remaining
98%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allowance Rate
447 granted / 604 resolved
+14.0% vs TC avg
Strong +24% interview lift
Without
With
+24.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
17 currently pending
Career history
611
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
43.6%
+3.6% vs TC avg
§102
26.7%
-13.3% vs TC avg
§112
20.2%
-19.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 604 resolved cases

Office Action

§102 §103 §112
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 § 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. Claim 16 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 16 recites the limitation "the cutaway portion" in line 2. There is insufficient antecedent basis for this limitation in the claim. Neither claim 15 nor claim 15, upon which claim 16 depends, recite a cutaway portion. Appropriate correction or clarification is required. 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. Claims 1-2, 8, 12, 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Polley, US 10,465,350. Regarding claim 1, Polley discloses a splash guard (10, see Figs. 1-9, col. 3, lines 35-50) for a syringe assembly (capable of use for a syringe, col. 3, lines 35-50), the splash guard comprising: first and second enclosure halves (30/40), each enclosure half comprising: a body (U-shaped body of 30/40, Fig. 9) having a side wall (sides walls of 30/40, Fig. 9), a top wall (50, Fig. 9, col. 4, lines 5-25) connected to the side wall along a top edge of the side wall, and a bottom wall (60, Fig. 9, col. 4, lines 5-25) connected to the side wall along a bottom edge of the side wall; an internal protrusion (90, Fig. 9) connected to an inner surface of the side wall and structured to guide the syringe assembly to a particular placement within the enclosure (col. 4, lines 5-25; 90 is capable of a tight fit with objects inside the portions 30/40); and an arm (110/120, Figs. 1, 5, 6, col. 4, lines 35-60) comprising a first end (end by outside of housing 30/40, Fig. 1) connected to an outer surface of the side wall opposite the inner surface, and a second end (end opposite of first end, Fig. 1) opposite the first end for gripping by a user; and a hinge (100, col. 4, lines 35-60), pivotably coupling the enclosure halves, biasing the arms towards an equilibrium state in which the second ends of the arms are positioned away from one another and the first ends of the arms impel the two enclosure halves together such that the two enclosure halves form a substantially enclosed cavity when engaged with the syringe assembly (col. 4, lines 35-60). Regarding claim 2, Polley discloses the splash guard of claim 1, wherein the body of each enclosure half is of semi-cylindrical shape (U-shape, col. 3, lines 50-65, such that the enclosure is of cylindrical shape (Figs. 1, 5, 6, col. 3, lines 50-65). Regarding claim 8, Polley discloses the splash guard of claim 1, wherein the protrusion of each enclosure half is of semi-annular shape (90 has a portion that is at least a U-shape, Fig. 9), such that the protrusions form an annular shape (Fig. 9). Regarding claim 12, Polley discloses the splash guard of claim 1, wherein the hinge comprises a torsion spring (160, Figs. 1, 5, 6, col. 4, lines 45-52). Regarding claim 14, Polley discloses the splash guard of claim 1, wherein the enclosure halves are formed from a material that is at least partially transparent (col. 3, lines 60-67, transparent plastic material). 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. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Polley in view of Anderson, US 7,635,153. Regarding claim 9, Polley discloses the splash guard of claim 1, but is silent as to wherein each enclosure half further comprises: a seal coupled to an inner edge of the protrusion to form a seal against the syringe assembly. However, Anderson, in the same field of art, namely, waste collection receptacles, teaches an enclosure with two halves where the enclosure has an additional seal in the form of a self-sealing lining that can be coupled to an inner edge to form a seal (140, col. 10, lines 34-45). It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the enclosure of Polley with an additional seal that would be attached to an inner edge of the protrusion as taught by Anderson in order to provide the stated advantages of providing sealing features to the enclosure and ensure waste collection (Anderson, col. 10, lines 35-55). Claims 13, 15, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Polley in view of Nadzadi et al, US 2023/0013867 A1. Regarding claim 13, Polley discloses the splash guard of claim 12, but is silent at to wherein each enclosure half is formed through a three-dimensional printing process. However, Nadzadi, in the same field of art, teaches a guard for a surgical tool, where the guard has an enclosure formed through a three-dimensional printing process (para [0073]). One of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that applying the known technique of three-dimensional printing as in Nadzadi to Polley would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of three-dimensional printing to manufacture the device of Polley would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such printing process. Further, applying three-dimensional printing to the guard of Polley, would have been recognized by one of ordinary skill in the art as resulting in an improved system that would allow more efficient way of producing the guard of Polley. Regarding claim 15, Polley discloses a method for manufacturing a splash guard for a syringe assembly (col. 3, lines 50-67, device 10 can be made of plastics), the method comprising: forming the splash guard (10), where the guard comprising: first and second enclosure halves (30/40), each enclosure half comprising: a body having a side wall, a top wall connected to the side wall along a top edge of the side wall, and a bottom wall connected to the side wall along a bottom edge of the side wall (see rejection of claim 1 above), an internal protrusion (90) connected to an inner surface of the side wall and structured to guide the syringe assembly to a particular placement within the enclosure (see rejection for claim 1 above), and an arm (110/120) comprising a first end connected to an outer surface of the side wall opposite the inner surface, and a second end opposite the first end for gripping by a user (see rejection for claim 1); and joining the enclosure halves at a pivot (150, Figs. 5-6) with a hinge (160) biasing the arms towards an equilibrium state in which the second ends of the arms are positioned away from one another and the first ends of the arms impel the two enclosure halves together such that the two enclosure halves form a substantially enclosed cavity when engaged with the syringe assembly (col. 4, lines 35-60). Polley is silent as to transmitting a three-dimensional (3D) model for the splash guard to be printed on a 3D printer, the 3D model and fabricating the enclosure halves using the 3D printer. However, Nadzadi, in the same field of art, teaches a guard for a surgical tool, where the guard has an enclosure (78) formed through a three-dimensional printing process (para [0073]); where the method includes transmitting a three-dimensional (3D) model for the guard to be printed on a 3D printer (para [0073]), the 3D model and fabricating the enclosure using the 3D printer (para [0073]). One of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that applying the known technique of three-dimensional printing as in Nadzadi to Polley would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of three-dimensional printing to manufacture the device of Polley would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such printing process. Further, applying three-dimensional printing to the guard of Polley, would have been recognized by one of ordinary skill in the art as resulting in an improved system that would allow more efficient way of producing the guard of Polley. Regarding claim 19, Polley as modified discloses the method of claim 15, and Nadzadi teaches wherein fabricating the enclosure halves using the 3D printer comprises printing each enclosure half monolithically (para [0072]). Regarding claim 20, Polley as modified discloses the method of claim 15, and Nadzadi as combined with Polley teaches wherein fabricating the enclosure halves using the 3D printer comprises printing the enclosure with a material that is at least partially transparent (Polley, transparent material, col. 3, lines 60-67). Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Polley and Nadzadi as applied to claim 15 above, and further in view of Anderson. Regarding claims 16-17, Polley as modified discloses the method of claim 15, wherein each enclosure half further comprises: a seal coupled to an inner edge of the cutaway portion of the bottom wall to form a waterproof seal against a filter of the syringe assembly; or wherein each enclosure half further comprises: a seal coupled to an inner edge of the protrusion to form a seal against the syringe assembly. However, Anderson, in the same field of art, namely, waste collection receptacles, teaches an enclosure with two halves where the enclosure has an additional seal in the form of a self-sealing lining that can be coupled to an inner edge to form a seal (140, col. 10, lines 34-45). It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the enclosure of Polley with an additional seal that would be attached to an inner edge of the protrusion as taught by Anderson in order to provide the stated advantages of providing sealing features to the enclosure and ensure waste collection (Anderson, col. 10, lines 35-55). Allowable Subject Matter Claims 3-7, 10-11, 18 are 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 The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST. 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. /KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
Read full office action

Prosecution Timeline

Jun 28, 2024
Application Filed
Jul 16, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

Precedent Cases

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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
74%
Grant Probability
98%
With Interview (+24.5%)
3y 1m (~1y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 604 resolved cases by this examiner. Grant probability derived from career allowance rate.

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