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 02/17/2026 has been entered. Claims 14-15 & 17-25 are pending in the application. Claims 1-13 & 16 are cancelled.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are as follows.
“drive mechanism” in Claim 25, where the generic placeholder is “mechanism”, and the functional language is “drive” or “reciprocating said coupler is an axial direction”, and sufficient modifying structure is not provided; instant application Page 11, Line 28, describe the drive mechanism as a motor, providing sufficient modifying structure
“energizer element” in Claims 14 & 17, where the generic placeholder is “element”, and the functional language is “energizer”, and sufficient modifying structure is not provided; instant application Page 9, Lines 3-4, describe the energizer element as an elastomeric O-ring or spring, providing sufficient modifying structure
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 14-15 & 17-20 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.
As to Claim 14, the phrase “the interior of the pump casing”, in Lines 14-15, lacks antecedent basis.
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 14 & 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mizukoshi (U.S. PGPub 2019/0101107)
As to Claim 14, Mizukoshi teaches a syringe pump for aspirating and dispensing fluids (10A), the syringe pump (10A) comprising:
a pump casing (11) having an inlet port (16) and an outlet port (17);
a ceramic (Paragraph 0024) piston liner (12A) received within (as shown in Figure 4) the pump casing (11), the piston liner (12A) having an internal bore (12a) formed by a cylindrical wall (the wall formed by bore 12a within 12A, as shown in Figure 4), the cylindrical wall (the wall formed by bore 12a within 12A, as shown in Figure 4) further defining a fluid path (the path between 16/17, as piston 13 rotates, as described in Paragraph 0026) between (as shown in Figure 4) the inlet port (16) and the outlet port (17) of the pump casing (11);
a ceramic (Paragraph 0024) piston (13) axially (left and right, as viewed in Figure 4) movable within (Paragraph 0026) said bore (12a) of said piston liner (12A) to urge a flow of fluid (Paragraph 0026) between said inlet port (16) and said outlet port (17) via said fluid path (the path between 16/17, as piston 13 rotates, as described in Paragraph 0026);
an annular cartridge seal (14) circumferentially sealing (as shown in Figure 4, where annular cartridge seal 14 is in contact with piston 13, resulting in a partial seal, as described in Paragraph 0022) an outer surface (the surface of piston 13 in contact with cartridge seal 14, as shown in Figure 4) of said ceramic piston (13) at a proximal end (the left side of liner 12A, as viewed in Figure 4) of said ceramic piston liner (12A);
an annular scraper (Mizukoshi seal 29 may be broadly interpreted as a “scraper” seal since seal 29 will apply radial pressure to the radially inner lip forming the groove within which energizer element 32 sits to “scrape” fluid from piston 13 during operation) seal (29) disposed adjacent (as shown in Figure 4) the annular cartridge seal (14), the annular scraper seal (29) comprising a lip portion (see Figure 4 below) positioned against (as shown in Figure 4) the outer surface (the surface of piston 13 in contact with cartridge seal 14, as shown in Figure 4) of the piston (13) and an energizer element (32; note Paragraph 0056 states a metal spring or an O-ring may be used) positioned in (as shown in Figure 4) an annular groove (the annular groove of annular scraper seal 29 within which energizer element 32 sits, as viewed in Figure 4), the annular groove (the annular groove of annular scraper seal 29 within which energizer element 32 sits, as viewed in Figure 4) opening in a direction away from (to the left, as shown in Figure 4) the interior (the internal volume of casing 11, as viewed in Figure 4) of the pump casing (11); and
a gland nut (23) attached to (as shown in Figure 4) a proximal end (the left side of 11, as viewed in Figure 4) of said pump casing (11), said gland nut (23) retaining (as shown in Figure 4) said annular cartridge seal (14) and said annular scraper seal (29) in engagement with (as shown in Figure 4) the piston (13).
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Mizukoshi Figure 4, Modified by Examiner
As to Claim 17, Mizukoshi teaches all the limitations of Claim 14, and continues to teach the lip portion (see Mizukoshi Figure 4 in the Claim 14 rejection above) is urged into engagement with (Paragraph 0046) the piston (13) by the energizer element (32).
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mizukoshi, in view of Bensley (U.S. PGPub 2010/0301069), in view of Zeitz (U.S. Patent 4,479,759).
As to Claim 15, Mizukoshi teaches all the limitations of Claim 14, and continues to teach the internal bore (12a) of the piston liner (12A) has an inner diameter (see Figure 4 in the Claim 14 rejection above) and the piston (13) has an outer diameter (see Figure 4 in the Claim 14 rejection above), a clearance (the clearance described in Paragraph 0045) between the inner diameter (see Figure 4 in the Claim 14 rejection above) and the outer diameter (see Figure 4 in the Claim 14 rejection above)…
the ceramic piston (13) outer surface (the surface of piston 13 in contact with cartridge seal 14, as shown in Figure 4) has a hardness on the Mohs scale of 8-13 (Paragraph 0024).
Mizukoshi is silent on the width of the clearance, so does not explicitly teach the clearance between the inner diameter and the outer diameter being in the range of 0.000100" to 0.000325”. Additionally, it is not clear how to convert Mohs to Vickers, so Mizukoshi does not explicitly teach the ceramic piston comprises an outer surface with a hardness on the Vickers scale of about 1700.
Bensley describes a similar pump, and teaches a clearance between the inner diameter (the diameter of passageway 111) of the liner (110) and the outer diameter (the diameter of the outer surface of piston 120) between 0.00005” and 0.0005” (Paragraph 0014).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the clearance, as taught by Mizukoshi, within the range, as taught by Bensley, to allow sealing between the two structures without mechanical seals (Paragraph 0014).
The Mizukoshi, as modified with Bensley, clearance encapsulates the claimed clearance range, but does not explicitly teach a clearance between the inner diameter and the outer diameter being in the range of .000100” to .000325”.
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the clearance between the inner diameter and the outer diameter to be in the range of .000100” to .000325”, since it has been held that “[i]n
the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a
prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA
1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant
appears to have placed no criticality on the claimed range (see instant application Page 3, Line 28, to Page 4, Line 1, which only state the clearance “is preferably” within the claimed range).
Zeitz describes a reciprocating piston within a cylinder, and teaches the hardness of the outer surface of the piston (107) is a result-effective variable (Column 8, Liens 22-31) which affects the wearing of the material creating a seal between the piston and internal bore (see MPEP 2144.05(II)(B)).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the ceramic piston outer surface with a hardness on the Vickers scale of about 1700, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. in re Aller, 105 USPQ 233. (1955)
Allowable Subject Matter
Claims 21 & 23-25 are allowed.
Claims 18-20 & 22 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As to Claim 18, the prior art of record teaches a syringe pump with a pump housing, ceramic piston and piston liner, a cartridge seal, a scraper seal with a lip portion, and a gland nut; the scraper seal comprises an energizer element within an annular groove. The prior art does not teach “the gland nut connects to an inner surface of the pump casing”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 18. The closest art of record is Mizukoshi (cited above). However, Mizukoshi describes the gland nut connecting to an outer surface of the pump casing. It would not be obvious to one of ordinary skill in the art to modify Mizukoshi without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 18, is neither anticipated nor made obvious by the prior art of record.
As to Claim 19, the prior art of record teaches a syringe pump with a pump housing, ceramic piston and piston liner, a cartridge seal, a scraper seal with a lip portion, and a gland nut; the gland nut comprises a stepped structure. The prior art does not teach “a first face retains the annular cartridge seal and a second face retains the annular scraper seal”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 19. The closest art of record is Bensley (cited above). However, Bensley describes the gland nut only engaging the annular cartridge seal with a face, not the scraper seal with a face. It would not be obvious to one of ordinary skill in the art to modify Bensley without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 19, is neither anticipated nor made obvious by the prior art of record.
As to Claim 20, the prior art of record teaches a syringe pump with a pump housing, ceramic piston and piston liner, a cartridge seal, a scraper seal with a lip portion, and a gland nut; the scraper seal comprises an energizer element within an annular groove. The prior art does not teach “an annular elastomeric washer positioned between the annular cartridge seal and the annular scraper seal”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 20. The closest art of record is Mizukoshi (cited above). However, Mizukoshi describes the annular cartridge seal in direct contact with the annular scraper seal. It would not be obvious to one of ordinary skill in the art to modify Mizukoshi without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 20, is neither anticipated nor made obvious by the prior art of record.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
Regarding the 112 rejections, Applicant did not address one of the rejections in Claim 14, so the rejection is maintained.
Regarding the 102 rejections for Claim 14, Applicant argues Mizukoshi does not teach an annular cartridge seal circumferentially sealing an outer surface of said ceramic piston at a proximal end of said ceramic piston liner. Examiner disagrees.
Mizukoshi teaches an annular cartridge seal, referenced as Element 14, which at least partially prevents fluid from flowing between piston 13 and liner 12A. Although the primary intent of Mizukoshi 14 may be to act as a replaceable spacer, Element 14 also acts as a seal. Therefore, Mizukoshi teaches each of the limitations of Claim 14.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783