DETAILED CORRESPONDENCE
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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-12, 19-22, drawn to a sample collection device.
Group II, claim(s) 13-16, drawn to collection kit.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a sample collection apparatus comprising: a filling assembly comprising: an inlet port for receiving a sample fluid; and an outlet port fluidly connected to the inlet port by a fluid channel; a receiving syringe having a first end with an aperture for engaging with the filling assembly and a second end comprising an injection needle; a fluid conducting element inside the receiving syringe extending from the outlet port of the filling assembly toward the second end of the receiving syringe adjacent the injection needle to direct fluid to the bottom of the receiving syringe; and a pressure release structure in the receiving syringe to release pressure in the receiving syringe as sample fluid flows via the fluid conducting element, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Bailey, D (US 4133304; hereinafter “Bailey”; already of record). Bailey teaches a sample collection apparatus (Bailey; Title, Fig. 1-6) comprising: a filling assembly comprising: an inlet port for receiving a sample fluid; and an outlet port fluidly connected to the inlet port by a fluid channel (Bailey teaches a filling assembly 23 with an inlet port at the top near 22 and outlet port at the bottom near 24 which are connected by a channel; Fig. 1-6); a receiving syringe having a first end with an aperture for engaging with the filling assembly and a second end comprising an injection needle (Bailey teaches a receiving syringe 54 which includes an aperture at the top that engages with the filling assembly at 24, and with a needle 52 at the bottom end; Fig. 1-6); a fluid conducting element inside the receiving syringe extending from the outlet port of the filling assembly toward the second end of the receiving syringe adjacent the injection needle to direct fluid to the bottom of the receiving syringe (Bailey teaches a fluid conducting element 70/74 that extends from the outlet port 24 toward the needle 52; Fig. 1-6, 12); and a pressure release structure in the receiving syringe to release pressure in the receiving syringe as sample fluid flows via the fluid conducting element (Bailey teaches that 70 has a hole through with the needle protrudes, the hole being the pressure release structure, such that fluid can flow to/from needle 52, and when the needle is removed and the hole is no longer present that a seal is created such that the hole is what breaks the pressure from the seal; Fig. 1-6, col. 6 lines 26-49. Bailey also teaches a hole at the top of the that creates a fluid pathway to release air through the top of the syringe 54, whereby the air is able to pass all the way to the top; Fig. 1-6, 12, col. 5 line 3-13).
During a telephone conversation with Erin Engelhardt on 10/23/25 a provisional election was made without traverse to prosecute the invention of group I, claims 1-12, 19-22. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/20/23 and 12/11/24 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1-16, 19-22 are pending with claims 1-12, 19-22 being examined and claims 13-16 deemed withdrawn.
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: “pressure release structure…to release pressure…” in lines 10-11 of claim 1.
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.
The specification describes the “pressure release structure…to release pressure…” as a hole, or aperture, or valve, or seal obstructor (see [83, 97] of specification) and also as a thin wire that encircles the circumference of the top of the receiving syringe and extends along the inside of the receiving syringe and terminates at a location above the injection needle (see [110] of the specification), and these are the “structure”/means that will be interpreted as “pressure release structure…to release pressure…” for purposes of examination.
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.
Claim 19 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 pre-AIA the applicant regards as the invention.
As to claim 19, it is unclear how the thin wire that extends along the inside of the syringe is enough to release pressure. Specifically, a wire alone does not have the ability to release pressure, and this is unclear without further clarification. The pressure release structure is interpreted under 112(f) (see above). A potential structure under this 112(f) interpretation may be a thin wire that encircles the circumference of the top of the receiving syringe and extends along the inside of the receiving syringe and terminates at a location above the injection needle as disclosed by the specification (see [110] of the specification). However, this is not what is recited in claim 19 and therefore claim 19 is unclear since it is unclear how a wire alone accomplishes pressure relief absent the relationship of encircling the top of the syringe, since the encircling (based on the specification) seems to be required in order to provide pressure relief.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 7-10, 12, 20-22 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Bailey, D (US 4133304; hereinafter “Bailey”; already of record).
As to claim 1, Bailey teaches a sample collection apparatus (Bailey; Title, Fig. 1-6) comprising: a filling assembly comprising: an inlet port for receiving a sample fluid; and an outlet port fluidly connected to the inlet port by a fluid channel (Bailey teaches a filling assembly 23 with an inlet port at the top near 22 and outlet port at the bottom near 24 which are connected by a channel; Fig. 1-6); a receiving syringe having a first end with an aperture for engaging with the filling assembly and a second end comprising an injection needle (Bailey teaches a receiving syringe 54 which includes an aperture at the top that engages with the filling assembly at 24, and with a needle 52 at the bottom end; Fig. 1-6); a fluid conducting element inside the receiving syringe extending from the outlet port of the filling assembly toward the second end of the receiving syringe adjacent the injection needle to direct fluid to the bottom of the receiving syringe (Bailey teaches a fluid conducting element 70/74 that extends from the outlet port 24 toward the needle 52; Fig. 1-6, 12); and a pressure release structure in the receiving syringe to release pressure in the receiving syringe as sample fluid flows via the fluid conducting element (Bailey teaches that 70 has a hole through with the needle protrudes, the hole being the pressure release structure, such that fluid can flow to/from needle 52, and when the needle is removed and the hole is no longer present that a seal is created such that the hole is what breaks the pressure from the seal; Fig. 1-6, col. 6 lines 26-49. Bailey also teaches a hole at the top of the that creates a fluid pathway to release air through the top of the syringe 54, whereby the air is able to pass all the way to the top; Fig. 1-6, 12, col. 5 line 3-13).
Note: The instant Claims contain a large amount of functional language (ex: “for…”, “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Bailey teaches the apparatus of claim 1, wherein the inlet port in the filling assembly is sized to fluidly connect with a transfer pipette for receiving sample fluid under pressure (The examiner notes that how the port is sized is a matter of intended use and function not further defining the device structure since the transfer pipette is not positively recited or part of the claimed device and since any size transfer pipette could be created/configured. Bailey teaches a filling assembly 23 with an inlet port at the top near 22 which is capable of connecting to any structure that is configured appropriately; Fig. 1-6).
As to claim 7, Bailey teaches the apparatus of claim 1, wherein the fluid channel in the filling assembly comprises a flow restrictor (Bailey teaches a flow restrictor as a shoulder that reduces diameter at the lower end near 24, and also as a tapering at 30; Fig. 1-6).
As to claim 8, Bailey teaches the apparatus of claim 1, wherein the fluid conducting element comprises a hollow shaft (Bailey teaches the fluid conducting element 70/74 as a hollow shaft; Fig. 1-6, 12).
As to claim 9, Bailey teaches the apparatus of claim 1, wherein the fluid conducting element comprises a channel guide which, together with a sidewall of the receiving syringe, forms a fluid channel (Bailey teaches the fluid conducting element 70/74 as a channel formed by the interior sidewall of the receiving syringe 54 together with 70/74; Fig. 1-6, 12).
As to claim 10, Bailey teaches the apparatus of claim 1, wherein the fluid conducting element comprises a polymer, metal, or a combination thereof (Bailey teaches 70 is formed of resilient material as silicone or rubber which are polymers; col. 3 line 52-53, col. 6 line 35-40).
As to claim 12, Bailey teaches the apparatus of claim 1, wherein the filling assembly engages with the receiving syringe via a friction fit feature, snap-fit feature, a flange-locking feature, or a combination thereof (Bailey teaches that the receiving syringe 12 is attached by a user, where the attachment includes the components fitting together via friction; col. 4 line 65-67, Fig. 1-6, 12).
As to claim 20, Bailey teaches the apparatus of claim 1, wherein the pressure release structure allows air to escape during filling of the receiving syringe (Bailey also teaches a hole at the top of the that creates a fluid pathway to release air through the top of the syringe 54, whereby the air is able to pass all the way to the top; Fig. 1-6, 12, col. 5 line 3-13).
As to claim 21, Bailey teaches the apparatus of claim 1, wherein the fluid conducting element makes continuous contact with the inside wall of the receiving syringe (Bailey teaches the fluid conducting element 70 that makes contact with inner part of the receiving syringe 54; Fig. 1-6, 12).
As to claim 22, Bailey teaches the apparatus of claim 1, wherein the fluid conducting element creates a substantially fluid-tight fluid channel where sample can flow from the first end of the receiving syringe through the fluid channel to the second end of the receiving syringe (Bailey teaches the fluid conducting element 70/74 as a channel formed by the interior sidewall of the receiving syringe 54 together with 70/74, whereby the channel is fluid tight and enables fluid flow; Fig. 1-6, 12).
Claims 1-2, 7-10, 12, 20-22 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Lin et al (US 20150283032; hereinafter “Lin”).
As to claim 1, Lin teaches a sample collection apparatus comprising: a filling assembly comprising: an inlet port for receiving a sample fluid; and an outlet port fluidly connected to the inlet port by a fluid channel (Lin teaches a filling assembly with an inlet at the top of 30 and an outlet at lower end of 30/31; Fig. 10, 24.); a receiving syringe having a first end with an aperture for engaging with the filling assembly and a second end comprising an injection needle (Lin teaches a syringe as the bottom portion of the figures, with a first end as the portion of at the region of 33 which engages with lower end of 30/31, and a second end with needle 34’; Fig. 10, 24.); a fluid conducting element inside the receiving syringe extending from the outlet port of the filling assembly toward the second end of the receiving syringe adjacent the injection needle to direct fluid to the bottom of the receiving syringe (Lin teaches a fluid conducting element 34; Fig. 10, 24. The fluid conducting element could also be just a region of space of 32 or of 34); and a pressure release structure in the receiving syringe to release pressure in the receiving syringe as sample fluid flows via the fluid conducting element (Lin teaches that the receiving syringe has an aperture in portion 20 through which 34 protrudes to enable fluidic connections, and Lin also teaches an air gap; Fig. 10, 24, [52, 57]).
Note: The instant Claims contain a large amount of functional language (ex: “for…”, “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Lin teaches the apparatus of claim 1, wherein the inlet port in the filling assembly is sized to fluidly connect with a transfer pipette for receiving sample fluid under pressure (The examiner notes that how the port is sized is a matter of intended use and function not further defining the device structure since the transfer pipette is not positively recited or part of the claimed device and since any size transfer pipette could be created/configured. Lin teaches inlet at the top of 30; Fig. 10, 24).
As to claim 7, Lin teaches the apparatus of claim 1, wherein the fluid channel in the filling assembly comprises a flow restrictor (Lin teaches that 32 tapers into 34 as part of the fluid channel; Fig. 10, 24).
As to claim 8, Lin teaches the apparatus of claim 1, wherein the fluid conducting element comprises a hollow shaft (Lin #34; Fig. 10, 24).
As to claim 9, Lin teaches the apparatus of claim 1, wherein the fluid conducting element comprises a channel guide which, together with a sidewall of the receiving syringe, forms a fluid channel (Lin teaches the sidewall of the syringe with the inner fluid element 34 serving as a channel guide within the sidewall of the syringe; Fig. 10, 24).
As to claim 10, Lin teaches the apparatus of claim 1, wherein the fluid conducting element comprises a polymer, metal, or a combination thereof (Lin; [114]).
As to claim 12, Lin teaches the apparatus of claim 1, wherein the filling assembly engages with the receiving syringe via a friction fit feature, snap-fit feature, a flange-locking feature, or a combination thereof (Lin teaches the components fit together via friction fit; Fig. 10, 24. Lin also teaches connections via interference or luer lock; [80]).
As to claim 20, Lin teaches the apparatus of claim 1, wherein the pressure release structure allows air to escape during filling of the receiving syringe (Lin teaches that the receiving syringe has an aperture in portion 20 through which 34 protrudes to enable fluidic connections, and Lin also teaches an air gap; Fig. 10, 24, [52, 57]).
As to claim 21, Lin teaches the apparatus of claim 1, wherein the fluid conducting element makes continuous contact with the inside wall of the receiving syringe (Lin teaches fluid conducting element making contact continuously with inner portion of sidewall 20, and also the portion of 32 as the fluidic connection making contact with the inner portion of the sidewall; Fig. 10, 24. The fluid conducting element is a region of space of upper portion of 32 or portion 34 that contacts the sidewalls).
As to claim 22, Lin teaches the apparatus of claim 1, wherein the fluid conducting element creates a substantially fluid-tight fluid channel where sample can flow from the first end of the receiving syringe through the fluid channel to the second end of the receiving syringe (Lin teaches the fluid conducting element 34 as a fluid tight channel; [81], Fig. 10, 24).
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bailey, D (US 4133304; hereinafter “Bailey”; already of record) in view of Cox et al (US 20240286139; hereinafter “Cox”).
As to claim 3, Bailey teaches the apparatus of claim 1, with the filling assembly disposed between the inlet and outlet port (see above).
Bailey does not specifically a filter between the inlet and outlet. However, Cox teaches the analogous art of fluid collection with a filter between the inlet and outlet (Cox teaches filter 16; Fig. 1-8, [54, 59, 61, 63]). It would have been obvious to one of ordinary skill in the art to have modified the filling assembly with the inlet and outlet ports of Bailey to have a filter disposed therebetween as in Cox because Cox teaches that a filter prevents and filters undesirable components from passing through (Cox; [63, 64, 92]).
Claims 4-5, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bailey, D (US 4133304; hereinafter “Bailey”; already of record) alone or alternatively in view of Schwartz, H (US 20190193072; hereinafter “Schwartz”).
As to claims 4-5, and 11, Bailey teaches the apparatus of claim 1, with the syringe receiving volume, receiving syringe diameter, and fluid conducting element that creates a fluid flow channel with a cross-sectional diameter (see above).
Bailey does not specifically teach the receiving syringe volume is 1 mL or less or the receiving syringe diameter is 4 mm or less, or a channel diameter of between about 0.05 and 3.0mm. However, it would have been obvious to have ensured or changed the size of the syringe volume and diameter to have been 1 mL or less and 4mm or less, respectively, or to change the channel diameter to between 0.05 to 3 mm, in order to provide the advantage of a syringe that aspirated only small microliter volumes of liquid (decreased volume) and a syringe that did not have wasted space (decreased diameter) since it has been held that changes in size/shape are not patentably distinct from prior art (MPEP 2144.04 IV). Alternatively, Schwartz teaches the analogous art of a sample collection apparatus (Schwartz; Title) with a receiving syringe volume is 1 mL or less or a receiving syringe diameter is 4 mm or less, or a channel diameter of between about 0.05 and 3.0mm (Schwartz teaches that the volume is 10 uL to 1 mL; [45]. Schwartz teaches that the diameter of the receiving syringe which is the inner portion of 5 shown in Fig. 5 is less than 4mm because the outer diameter is .161 in which is 4 mm, so the inner diameter must be less. Further, the diameter3 in Fig. 5b2 is .153 in which is less than 4 mm. Further, when looking at the inner diameter of 5, it is clear that the inner diameter is much smaller than ½ the diameter of Dia1 of 4 mm, such that the diameter is less than 2 mm). It would have been obvious to have modified the syringe volume and size of Bailey to have accommodated microliter volumes and had an inner diameter of less than 3mm as in Schwartz because Schwartz teaches that this size syringe is appropriate to handle microliter volumes (Schwartz; [45]), and also because this would provide the advantage of a syringe that aspirated only small microliter volumes of liquid (decreased volume) and a syringe that did not have wasted space (decreased diameter) since it has been held that changes in size/shape are not patentably distinct from prior art (MPEP 2144.04 IV).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bailey, D (US 4133304; hereinafter “Bailey”; already of record) in view of Lin et al (US 20150283032; hereinafter “Lin”).
As to claim 6, Bailey teaches the apparatus of claim 1, with the inlet port of the filling assembly (see above).
Bailey does not specifically teach the inlet is tapered. However, Lin teaches the analogous art of an apparatus for aspirating, which has a tapered inlet (Lin teaches tapered/sloped inlet to redirect the objects placed into it toward the desirable entry point; [60], Fig. 1). It would have been obvious to one of ordinary skill in the art to have modified the inlet port of the filling assembly of Bailey to have a tapered slope as in Lin because Lin teaches that the taper helps to redirect objects to their proper position (Lin; [60]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Bailey, D (US 4133304; hereinafter “Bailey”; already of record) in view of Capdevila et al (US 20180318504; hereinafter “Capdevila”).
As to claim 19, Bailey teaches the apparatus of claim 1, with the receiving syringe and injection needle (see above).
However, Capdevila teaches the analogous art of fluid syringe with a pressure release structure comprises a thin wire that extends along the inside of the receiving syringe and terminates at a location above the injection needle (Capdevila teaches that spring wire 36 extends inside of the syringe where the spring controls whether or not to seal the valve; [55, 57, 58], Figs. 1-5. Capdevila teaches that the spring terminates above the needle, as the needle is attached to outlet 18; [48], Fig. 2). It would have been obvious to one of ordinary skill in the art to have modified the receiving syringe of Bailey to have included the wire for releasing pressure as in Capdevila because Capdevila teaches that the wire helps to automatically lock the device if needed and also that it is advantageous to use the wire to be able to adjust and seal and unseal based on the desired force (Capdevila; [57, 58]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Pohl et al (US 20220290089; hereinafter “Pohl”) teaches a pressure relief vent with needles that protrude on either side to release pressure; Fig. 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Benjamin R Whatley whose telephone number is (571)272-9892. The examiner can normally be reached on Mon- Fri 8am-5pm.
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, Jill Warden can be reached on 5712721267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798