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 .
Response to Amendment
The Amendment filed on 6/19/2026 has been entered. Claims 1-8, 10-18, and 20 remain pending in the application.
Applicants amendments to the drawings have overcome the drawing objections previously set forth in the Non-final Office Action mailed 12/22/2025.
Applicants amendments to the abstract have overcome the abstract objections previously set forth in the Non-final Office Action mailed 12/22/2025.
Applicants amendments to the specification have overcome the specification objections previously set forth in the Non-final Office Action mailed 12/22/2025.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 12/22/2025.
Applicants amendments to the claims have failed to overcome all of the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 12/22/2025. Specifically, the rejection of “said annular groove” in claim 1 and claim 11 was not overcome.
Information Disclosure Statement
The information disclosure statement filed 6/3/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered. Applicant states in a letter submitted on 6/3/2026 with the information disclosure statement that a copy of the Japanese Office Action is included as a statement of relevance of documents that are not in English. The copy of the Japanese Office Action however is also not in English. It is unclear how/which specific part of the Japanese Office Action, which is not in English, serves as a statement of relevance.
The information disclosure statement filed 8/5/2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The copy of JP 20100022422 is not legible.
The information disclosure statement filed 8/5/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered. Applicant states in a letter submitted on 8/5/2026 with the information disclosure statement that copies of the Chinese Office Action and Japanese Notice of Allowance are included as a statement of relevance of documents that are not in English. The copies of the Chinese Office Action and Japanese Notice of Allowance however are also not in English. It is unclear how/which specific part of the Chinese Office Action and Japanese Notice of Allowance, which are not in English, serve as a statement of relevance.
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 1-8, 10-18, and 20 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.
In regard to claim 1,
Line 3 recites “said annular groove”. Line 2-3 recites "at least one annular groove". It is unclear if "said annular groove" refers to a specific groove of the at least one annular groove or if "said annular groove" is intended to refer to the at least one annular groove. For examination purposes Examiner construes "said annular groove" to be "said at least one annular groove". Examiner suggests replacing "said annular groove" in line 3 of claim 1 with "said at least one annular groove".
Examiner notes claims 2-8 and 10 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 11,
Line 5 recites “said annular groove”. Line 4 recites "at least one annular groove". It is unclear if "said annular groove" refers to a specific groove of the at least one annular groove or if "said annular groove" is intended to refer to the at least one annular groove. For examination purposes Examiner construes "said annular groove" to be "said at least one annular groove". Examiner suggests replacing "said annular groove" in line 5 of claim 11 with "said at least one annular groove".
Examiner notes claims 12-18 and 20 are similarly rejected by virtue of their dependency on claim 11.
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 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.
Claims 1-3, 7-8, 10-13, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Prakash (U.S. PG publication 20180318525) and further in view of Major (U.S. Patent no 5865803).
In regard to claim 1,
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Prakash discloses a plunger piston (figure 3, item 24, 40, and 100) comprising:
a plunger piston body (see body of the plunger piston 24, 40, and 100 in figure 3; Examiner notes item 24 includes item 21 and item 23 connected by connector 22 as disclosed in paragraph [0045]) comprising a front face (see labeled portion of figure 3 above OR figure 3, item 21; Examiner notes both the labeled portion of figure 3 above or item 21 can be construed as the front face) opposite a rear face (figure 3, item 23) and at least one annular groove (see figure 3 wherein a groove is present which item 45 is within; paragraph [0045]: “a rear seal 45 of the plunger head seal 40 sits in a groove created between seal holding disc 21 and the seal pushing disc 23”) positioned between said front face and said rear face (see figure 3 wherein the groove is located between the labeled portion of figure 3 above and 23 OR also between item 21 and 23), said annular groove including opposed sidewalls and a bottom (see figure 3);
a seal (figure 3, item 45) located in said at least one annular groove (See figure 3; paragraph [0045]), said seal being sized to contact at least a portion of said opposed sidewalls and said bottom (see figure 3); and
a plurality of channels (see channels formed by each item 100) extending from said front face into said at least one annular groove (see figure 3) through the plunger piston body (see figure 3), said plurality of channels providing communication between said front face and said seal (see figure 3) to equalize a pressure on the seal when the front face of the plunger piston is moved against a fluid (paragraph [0054], [0059], and [0061]-[0062]).
Prakash is silent that the seal in the at least one annular groove is specifically an O-ring and therefore fails to disclose an O-ring located in said at least one annular groove, said O-ring being sized to contact at least a portion of said opposed sidewalls and said bottom, and said plurality of channels providing communication between said front face and said groove O-ring to equalize a pressure on the O-ring when the front face of the plunger piston is moved against a fluid.
Major teaches an O-ring (figure 1, item 38) located in said at least one annular groove (see figure 2; column 4, line 25-32), said O-ring being sized to contact at least a portion of said opposed sidewalls and said bottom (see figure 2; column 4, line 25-32).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Prakash to substitute a suitably sized O-ring in place of the seal 45 in the groove of Prakash, as taught by Major, because the substitution is a simple substitution that would yield the same predictable result of providing an effective seal (column 4, line 25-32 of Major and paragraph [0006] and [0047] of Prakash: ”a rear side contact surface 44 of the plunger head seal 40 are in contact with an inner surface of the syringe body 1 to create a seal between the plunger head 24 and the syringe body 1”). Furthermore, Prakash supports modifications can be made (paragraph [0073] of Prakash). Examiner notes substituting a suitably sized O-ring in place of the seal 45 in the groove of Prakashan would result in an O-ring located in said at least one groove, said O-ring being sized to contact at least a portion of said opposed sidewalls and said bottom, and said plurality pf channels providing communication between said front face and said groove O-ring to equalize a pressure on the O-ring when the front face of the plunger piston is moved against a fluid.
In regard to claim 2,
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Prakash in view of Major teaches the plunger piston as recited in claim 1 wherein said front face (see labeled portion of figure 3 above of Prakash OR figure 3, item 21 of Prakash) includes an outer rim (figure 3 above of Prakash) and wherein said plurality of channels are located in said outer rim (see figure 3 of Prakash).
In regard to claim 3,
Prakash in view of Major teaches the plunger piston as recited in claim 2, wherein said plurality of channels have a depth that extends from said outer rim to the bottom of said at least one annular groove (see figure 3 of Prakash; Examiner notes said plurality of channels have a depth that extends from said outer rim to the bottom of said at least one annular groove and past the bottom of said at least one annular groove).
In regard to claim 7,
Prakash in view of Major teaches the plunger piston as recited in claims 1, wherein said front face (figure 3, item 21 of Prakash) has a diameter that is smaller than a diameter of said rear face (figure 3, item 23 of Prakash; see figure 3 of Prakash).
In regard to claim 8,
Prakash in view of Major teaches the plunger piston as recited in claim 1, wherein said rear face includes at least one detent (see figure 3, item 103 of Prakash which forms a detent).
In regard to claim 10,
Prakash in view of Major teaches the plunger piston as recited in claim 1, wherein said O-ring (see analysis of claim 1 above wherein the seal 45 of Prakash has been replaced with a suitable sized O-ring which contacts syringe 1 of Prakash) has an outer diameter that is greater than an outer diameter of said front face (figure 3, item 21 of Prakash; see figure 3 of Prakash and analysis of claim 1).
In regard to claim 11,
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Prakash discloses a syringe (figure 3, item 10) comprising:
a barrel (figure 3, item 1) and a plunger piston (figure 3, item 24, 40, and 100) received in said barrel (see figure 3):
said plunger piston comprising a plunger piston body (see body of the plunger piston 24, 40, and 100 in figure 3; Examiner notes item 24 includes item 21 and item 23 connected by connector 22 as disclosed in paragraph [0045]), the plunger piston body comprising a front face (see labeled portion of figure 3 above OR figure 3, item 21; Examiner notes both the labeled portion of figure 3 above or item 21 can be construed as the front face) opposite a rear face (figure 3, item 23) and at least one annular groove (see figure 3 wherein a groove is present which item 45 is within; paragraph [0045]: “a rear seal 45 of the plunger head seal 40 sits in a groove created between seal holding disc 21 and the seal pushing disc 23”) positioned between said front face and said rear face (see figure 3 wherein the groove is located between the labeled portion of figure 3 above and 23 OR also between item 21 and 23), said annular groove including opposed sidewalls and a bottom (see figure 3);
a seal (figure 3, item 45) located in said at least one annular groove (See figure 3; paragraph [0045]), said seal being sized to contact at least a portion of said opposed sidewalls and said bottom (see figure 3); and
a plurality of channels (see channels formed by each item 100) extending from said front face into said at least one annular groove (see figure 3) through the plunger piston body (see figure 3), said plurality of channels providing communication between said front face and said seal (see figure 3) to equalize a pressure on the seal when the front face of the plunger piston is moved against a fluid (paragraph [0054], [0059], and [0061]-[0062])..
Prakash is silent that the seal in the groove is specifically an O-ring and therefore fails to disclose an O-ring located in said at least one annular groove, said O-ring being sized to contact at least a portion of said opposed sidewalls and said bottom; and said plurality of channels providing communication between said front face and said O-ring to equalize a pressure on the O-ring when the front face of the plunger piston is moved against a fluid.
Major teaches an O-ring (figure 1, item 38) located in said at least one annular groove (see figure 2; column 4, line 25-32), said O-ring being sized to contact at least a portion of said opposed sidewalls and said bottom (see figure 2; column 4, line 25-32).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Prakash to substitute a suitably sized O-ring in place of the seal 45 in the groove of Prakash, as taught by Major, because the substitution is a simple substitution that would yield the same predictable result of providing an effective seal (column 4, line 25-32 of Major and paragraph [0006] and [0047] of Prakash: ”a rear side contact surface 44 of the plunger head seal 40 are in contact with an inner surface of the syringe body 1 to create a seal between the plunger head 24 and the syringe body 1”). Furthermore, Prakash supports modifications can be made (paragraph [0073] of Prakash). Examiner notes substituting a suitably sized O-ring in place of the seal 45 in the groove of Prakashan would result in an O-ring located in said at least one annular groove, said O-ring being sized to contact at least a portion of said opposed sidewalls and said bottom; and said plurality of channels providing communication between said front face and said O-ring to equalize a pressure on the O-ring when the front face of the plunger piston is moved against a fluid.
In regard to claim 12,
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Prakash in view of Major teaches the syringe as recited in claim 11 wherein said front face (see labeled portion of figure 3 above of Prakash OR figure 3, item 21 of Prakash) includes an outer rim (figure 3 above of Prakash) and wherein said plurality of channels are located in said outer rim (see figure 3 of Prakash).
In regard to claim 13,
Prakash in view of Major teaches the syringe as recited in claim 12, wherein said plurality of channels have a depth that extends from said outer rim to the bottom of said at least one groove (see figure 3 of Prakash; Examiner notes said plurality of channels have a depth that extends from said outer rim to a bottom of said at least one annular groove and past the bottom of said at least one annular groove).
In regard to claim 17,
Prakash in view of Major teaches the syringe as recited in claim 11, wherein said front face (figure 3, item 21 of Prakash) has a diameter that is smaller than a diameter of said rear face (figure 3, item 23 of Prakash; see figure 3 of Prakash).
In regard to claim 18,
Prakash in view of Major teaches the syringe as recited in claim 11, wherein said rear face includes at least one detent (see figure 3, item 103 of Prakash which forms a detent).
In regard to claim 20,
Prakash in view of Major teaches the syringe as recited in claim 11, wherein said O-ring (see analysis of claim 11 above wherein the seal 45 of Prakash has been replaced with a suitable sized O-ring which contacts syringe 1 of Prakash) has an outer diameter that is greater than an outer diameter of said front face (figure 3, item 21 of Prakash; see figure 3 of Prakash and analysis of claim 11).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Prakash (U.S. PG publication 20180318525) in view of Major (U.S. Patent no 5865803), and further in view of Fischer (U.S. Patent no 4986820).
In regard to claim 4,
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Prakash in view of Major teaches the plunger piston as recited in claim 2, wherein said outer rim (see outer rim of the labeled portion of figure 3 above of Prakash) has a shape (see figure 3 of Prakash).
Prakash in view of Major fails to disclose wherein said outer rim has a wedge shape.
Fischer teaches wherein said outer rim (see item 28 in figure 3) has a wedge shape (see figure 3 and 5).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the outer rim of Prakash in view of Major to be a wedge shape, as taught by Fischer, for the purpose of helping to provide a satisfactory fluid-tight seal (column 5, line 8-11 of Fischer). Examiner notes paragraph [00030] of the instant disclosure states “The outer rim 64 does not have to have a wedge shape for this inventive concept.”
In regard to claim 14,
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Prakash in view of Major teaches the syringe as recited in claim 12, wherein said outer rim (see outer rim of the labeled portion of figure 3 above of Prakash) has a shape (see figure 3 of Prakash).
Prakash in view of Major fails to disclose wherein said outer rim has a wedge shape.
Fischer teaches wherein said outer rim (see item 28 in figure 3) has a wedge shape (see figure 3 and 5).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the outer rim of Prakash in view of Major to be a wedge shape, as taught by Fischer, for the purpose of helping to provide a satisfactory fluid-tight seal (column 5, line 8-11 of Fischer). Examiner notes paragraph [00030] of the instant disclosure states “The outer rim 64 does not have to have a wedge shape for this inventive concept.”
Claims 5-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Prakash (U.S. PG publication 20180318525) in view of Major (U.S. Patent no 5865803), and further in view of Schuetz (U.S. PG publication 20130197467).
In regard to claim 5,
Prakash in view of Major teaches the plunger piston as recited in claim 1, wherein said plunger piston has a shape (see figure 3 of Prakash).
Prakash in view of Major is silent as to wherein said plunger piston has an oval shape.
Schuetz teaches wherein said plunger piston (figure 1, item 2) has an oval shape (paragraph [0025] and [0078]) and that an oval shape or other shape (circular, rectangular, quadratic) could all be used to achieve the same result (paragraph [0078] and [0025]) and thus an oval shape and other shape (circular, rectangular, quadratic) were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute an oval shape in place of the shape of the plunger piston of Prakash in view of Major since it has been held that substituting parts of an invention involves only routine skill in the art. Paragraph [00030] of the instant disclosure also states that the plunger piston “could also be circular as known in the art”.
In regard to claim 6,
Prakash in view of Major in view of Schuetz teaches the plunger piston as recited in claim 5, wherein said plurality of channels are oriented perpendicular to a centerline of said oval shape (see analysis of claim 5 above and figure 3 of Prakash).
In regard to claim 15,
Prakash in view of Major teaches the syringe as recited in claim 11, wherein said plunger piston has a shape (see figure 3 of Prakash) and wherein said barrel has an inner wall with a matching shape (see figure 3 of Prakash).
Prakash in view of Major is silent as to wherein said plunger piston has an oval shape and wherein said barrel has an inner wall with a matching oval shape.
Schuetz teaches wherein said plunger piston (figure 1, item 2) has an oval shape (paragraph [0025] and [0078]) and wherein said barrel (figure 1, item 1) has an inner wall with a matching oval shape (paragraph [0078]) and that an oval shape or other shape (circular, rectangular, quadratic) could all be used to achieve the same result (paragraph [0078] and [0025]) and thus an oval shape and other shape (circular, rectangular, quadratic) were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute an oval shape in place of the shape of the plunger piston of Prakash in view of Major and to substitute a matching oval shape in place of the shape of the inner wall of the barrel of Prakash in view of Major since it has been held that substituting parts of an invention involves only routine skill in the art. Paragraph [00030] of the instant disclosure also states that the plunger piston “could also be circular as known in the art”.
In regard to claim 16,
Prakash in view of Major in view of Schuetz teaches the syringe as recited in claim 15 wherein said plurality of channels are oriented perpendicular to a centerline of said oval shape (see analysis of claim 15 above and figure 3 of Prakash).
Response to Arguments
Applicant's arguments filed 6/19/2026 have been fully considered but they are not persuasive. In regard to the rejections under 35 U.S.C. 112, Applicant argues the claims have been amended to address the 35 U.S.C. 112 rejections. As noted above, the rejection of “said annular groove” in line 3 of claim 1 and line 5 of claim 11 were not addressed. No other arguments regarding the rejections under 35 U.S.C. 112 have been included. Accordingly, the rejection under 35 U.S.C. 112 still remains.
Applicant argues that the syringe of Parish (Examiner assumes this is a typo as Prakash, not Parish, was cited in the 103 rejections above) is a single use syringe. Applicant argues that the channels formed in plunger head 40 do not equalize a pressure on the seal 40 when plunger 20 is moved against a fluid. Examiner respectfully disagrees. Air is a fluid. As disclosed in paragraph [0061]-[0062] of Prakash, the channels formed in plunger head 40 do equalize a pressure on the seal 40 when plunger 20 is moved against air. Additionally, paragraph [0059] of Prakash specifically states “the piercing objects 100 mounted on the plunger head 40 provide for an equalizing of differential pressure across the plunger head seal 40 after a first injection operation of the syringe assembly”. Applicant’s arguments are therefore not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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