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 .
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) 1-31, drawn to a variable volume fluid dispenser.
Group II, claim(s) 32-33, drawn to a method of filling the dispensing chamber of a variable volume fluid dispenser.
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 variable volume fluid dispenser for medical therapy and diagnostic use, the variable volume fluid dispenser comprises: a tubular body having a proximal end and a distal end, wherein the tubular body defines an interior volume between the proximal end and the distal end; a fluidic connector on each of the proximal end and the distal end; and a piston located within the interior volume, wherein the piston is configured to move axially between the proximal end and the distal end under the action of fluid displacement via the fluidic connectors, wherein the piston position relative to the distal end defines the volume of fluid to be dispensed, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Hottovy et al. (US 8,617,123 B2). Hottovy teaches a variable volume fluid dispenser (figure 1) for medical therapy and diagnostic use, the variable volume fluid dispenser comprises: a tubular body 12 having a proximal end 18 and a distal end 16, wherein the tubular body 12 defines an interior volume (interior volume of element 12) between the proximal end and the distal end; a fluidic connector 14, 28 on each of the proximal end and the distal end; and a piston 24 located within the interior volume, wherein the piston 24 is configured to move axially (column 6, lines 64-67, column 7, lines 15-30, 48-61) between the proximal end and the distal end under the action of fluid displacement via the fluidic connectors, wherein the piston position relative to the distal end defines the volume of fluid to be dispensed
During a telephone conversation with Michael Malinzak on 2/19/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-31. Affirmation of this election must be made by applicant in replying to this Office action. Claims 32, 33 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other 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).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Specification
The disclosure is objected to because of the following informalities:
The reference characters “10” on page 7, line 3 and “30” on page 7, line 3 are both used to refer to “piston”.
Appropriate correction is required.
Claim Objections
Claims 1, 8-11, 13-15, 20 are objected to because of the following informalities:
Claim 1 recites the limitation “the action” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, last line, the recitation “the volume of fluid” appears to be amended to recite “a volume of the fluid” to correct the antecedent basis for the recitation “the volume” and refer to “fluid” recited in claim 1, line 7.
Regarding claims 8-11, 14, 15, lines 1-2, the recitation “one or both fluidic connectors” appears to be amended to recite “the one or both fluidic connectors” in order to refer to both fluidic connectors recited in claim 1.
Regarding claim 13, line 3, the recitation “fluid flow” appears to be amended to recite “the fluid flow” in order to refer to “fluid flow” recited in claim 13, line 2.
Claim 20 recites the limitation “the distal end” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 20, line 4, the recitation “fluid” appears to be amended to recite “the fluid” in order to refer to “fluid” recited in claim 1, line 7.
Regarding claim 20, line 4, the recitation “tubular body” appears to be amended to recite “the tubular body” in order to refer to “tubular body” recited in claim 1, line 3.
Regarding claim 24, line 4, the recitation “fluid” in the limitation “when fluid acts” appears to be amended to recite “the fluid” in order to refer to “fluid” recited in claim 1, line 7.
Appropriate correction is required.
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 2, 30 and 31 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.
Regarding claim 2, the recitation “fluid” in the limitation “a volume of dispensing fluid” renders the claim indefinite because the claim is unclear if “fluid” in claim 2 refers to “fluid” recited in claim 1, line 7 or additional. For examination purposes, examiner construes “fluid” recited in claim 2 is same as “fluid” recited in claim 1.
Claims 30 and 31 recite the recitation “The neurosurgical apparatus” in line 1. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the claim is unclear if “the dispenser” in claim 1 is same as “neurosurgical apparatus” recited in claim 30, comprises “neurosurgical apparatus” or different. For examination purposes, examiner construes that “The neurosurgical apparatus” is same as “the dispenser”.
Claim 31 being dependent on claim 30 is also rejected.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 (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 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 1-4, 6-15, 19, 22-24 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kriesel (US 5,569,236).
Regarding claim 1, Kriesel teaches a variable volume fluid dispenser (figures 8, 11, 18-19) for medical therapy and diagnostic use, the variable volume fluid dispenser comprises:
a tubular body (body of elements 104, 180) having a proximal end 104c, 180b and a distal end 104b, 180a wherein the tubular body (body of elements 104, 180) defines an interior volume (hollow portion inside elements 104, 180) between the proximal end and the distal end;
a fluidic connector 112, 132, 130, 194, 196, 198, 166, 216, 200a, 220 (or 201 engaged with element 227) on each of the proximal end and the distal end; and
a piston 106, 182, “P” located within the interior volume, wherein the piston is configured to move axially between the proximal end and the distal end (column 12, lines 32-36) under the action of fluid displacement via the fluidic connectors, wherein the piston position relative to the distal end defines the volume (volume occupied by fluid/drug) of fluid to be dispensed.
Regarding claim 2, Kriesel teaches wherein the piston 106, 182, “P” is operable to divide the interior volume into a proximal volume (volume between element 106, 182, “P” and end at element 104c, 180b) and a distal volume (volume between element 106, 182, “P” and end at element 104b, 180a), wherein a volume of dispensing fluid (volume of fluid/medication inside the chamber will be less than entire volume in the hollow portion inside elements 180 and 104 because the portion of the volume inside elements 180 and 104 will be occupied by piston 106, 182, “P”), which is less than the capacity of the interior volume is contained in the distal volume.
Regarding claim 3, Kriesel teaches wherein the tubular body is formed from a rigid pharmacologically inert material (column 9, lines 11-13, “glass”).
Regarding claim 4, Kriesel teaches wherein the tubular body is made of glass (column 9, lines 11-13, “glass”).
Regarding claim 6, Kriesel teaches wherein the tubular body is made of plastic (column 9, lines 11-13, “plastic”).
Regarding claim 7, Kriesel teaches wherein the tubular body is made of laboratory grade polypropylene and/or polyethylene resins (column 9, lines 49-52).
Regarding claim 8, Kriesel teaches wherein one or both fluidic connectors comprise a hollow needle 229 (figure 19).
Regarding claim 9, Kriesel teaches wherein one or both fluidic connectors comprise a seal 216 pierceable by a hollow needle 214.
Regarding claim 10, Kriesel teaches wherein one or both fluidic connectors comprise a split seal 216 that can be opened to facilitate fluid flow.
Regarding claim 11, Kriesel teaches wherein one or both fluid connectors comprise a valve (figure 10A), which can be opened/activated by connection to an activating reciprocal connecting member 140 (column 12, line 65-column 13, line 8).
Regarding claim 12, Kriesel teaches wherein the valve is a mechanical valve, which requires physical activation of the valve to permit fluid flow (column 11, lines 27-31, column 12, line 65-column 13, line 18).
Regarding claim 13, Kriesel teaches wherein the valve is a pressure sensitive valve, which is operable to open upon fluid flow and to close when fluid flow stops (column 11, lines 27-31, column 12, line 65-column 13, line 18).
Regarding claim 14, Kriesel teaches wherein one or both fluidic connectors comprise a needleless connector, 194, 196, 198, 216, 220.
Regarding claim 15, Kriesel teaches wherein one or both fluidic connectors comprise a removable cap 220.
Regarding claim 19, Kriesel teaches wherein the distal end connecting member is a Luer fitting (column 10, lines 15-23), which is configured to connect with a reciprocal Luer fitting.
Regarding claim 22, Kriesel teaches wherein the piston 106 includes a perimeter seal member 106a operable to create a fluid and gas seal within the interior volume of the tubular body.
Regarding claim 23, Kriesel teaches wherein the perimeter seal member 106a includes one or more contact surfaces (surface of element 106a).
Regarding claim 24, Kriesel teaches wherein the perimeter seal 106a is configured with low friction properties, such that movement of the piston 106 relative to the inner surface of the dispenser is free with very little resistance when fluid acts on the distal or proximate surface of the piston (column 10, lines 6-15).
Regarding claim 29, Kriesel teaches further comprising a cannula 229 (figure 19) for connection to the distal fluidic connector (element 201 engaged with element 227).
Claim(s) 1 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ericson et al. (US 2,017,276).
Regarding claim 1, Ericson teaches a variable volume fluid dispenser (figure 1) for medical therapy and diagnostic use, the variable volume fluid dispenser comprises:
a tubular body 14 having a proximal end (end of element 14 comprising element 18) and a distal end (end of element 14 comprising element 15), wherein the tubular body 14 defines an interior volume (volume inside element 10) between the proximal end and the distal end;
a fluidic connector 15, 19 on each of the proximal end and the distal end; and
a piston 12 located within the interior volume (volume inside element 10), wherein the piston 12 is configured to move axially between the proximal end and the distal end under the action of fluid displacement via the fluidic connectors (page 2, lines 54-61 in second column, “when the air admission valve … the bore of the needle”), wherein the piston 12 position relative to the distal end defines the volume of fluid (volume of fluid inside element 10) to be dispensed.
Regarding claim 17, Ericson teaches wherein the distal end fluid connector 15 includes a connecting member 13a incorporating a hollow needle 13 (element 13 is configured to perform the function as claimed in claim 17) configured to pierce a pierceable reciprocal connecting member provided on apparatus to which the dispenser is to be connected.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Tischlinger (US 3,885,297).
Regarding claim 5, Kriesel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Kriesel is silent regarding wherein the tubular body is made of borosilicate glass.
However, Tischlinger teaches a design of a syringe in background wherein the body is made of borosilicate glass (column 1, lines 35-38) for the purpose of manufacturing a tubular body having high order of chemical inertness (column 1, lines 35-38).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the glass material of Krisel to incorporate borosilicate glass as taught by Tischlinger for the purpose of a tubular body having high order of chemical inertness (column 1, lines 35-38).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Gibson (US 2015/0374919 A1).
Regarding claim 16, Kriesel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Kriesel further discloses the proximal end fluidic connector 220 including vents for gas passage (column 14, lines 66-67) but is silent regarding wherein the proximal end fluidic connector comprises a septum stopper pierceable by a hollow needle.
However, Gibson teaches a design of a dispenser (figure 9) comprising a fluidic connector 656 comprises a septum stopper 656 pierceable by a hollow needle 702 for the purpose of storing the hollow needle into the sterile environment (paragraph 0071) and reduce the time and material needed for preparing the dispenser to dispense the fluid (paragraph 0004).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the proximal end fluidic connector to incorporate a septum stopper pierceable by a hollow needle as taught by Gibson for the purpose of storing the hollow needle into the sterile environment (paragraph 0071) and reduce the time and material needed for preparing the dispenser to dispense the fluid (paragraph 0004).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236).
Regarding claim 18, Kriesel discloses wherein the proximal end connecting member 220 is a fitting (fitting used for element 220 to connect), which is configured to connect with a reciprocal fitting (fitting on element 104 that allows connection with element 220).
Kriesel is silent regarding the fitting and a reciprocal fitting being a Luer fitting in one embodiment. However, Kriesel teaches in a different embodiment (figure 8) wherein the fitting is a Luer fitting (column 10, lines 15-20) for the purpose of using a well-known form of an alternative fitting (column 10, lines 15-20).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the fitting type of one embodiment of Kriesel to incorporate a Luer fitting as taught by different embodiment of Kriesel for the purpose of using a well-known form of an alternative fitting (column 10, lines 15-20).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of McNaughton (US 5,024,660).
Regarding claim 20, Kriesel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Kriesel is silent regarding wherein at least an axial portion of the tubular body is transparent and includes markings internally or externally to indicate the position of the distal end of the piston, thereby indicating volume of fluid contained within tubular body.
However, McNaughton teaches a design of a dispenser (figure 1) wherein at least an axial portion of the tubular body is transparent (column 2, lines 43-47) and includes markings 14 internally or externally to indicate the position of the distal end of the piston, thereby indicating volume of fluid contained within tubular body for the purpose of determining the fluid inside the tubular body (column 2, lines 43-47).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the tubular body of Kriesel to incorporate wherein at least an axial portion of the tubular body is transparent and includes markings internally or externally to indicate the position of the distal end of the piston, thereby indicating volume of fluid contained within tubular body as taught by McNaughton for the purpose of determining the fluid inside the tubular body (column 2, lines 43-47).
Regarding claim 21, Kriesel discloses the claimed invention substantially as claimed, as set forth above in claim 1. Kriesel is silent regarding wherein the markings include a calibrated scale including graduated marks.
However, McNaughton teaches wherein the markings include a calibrated scale including graduated marks 14 (markings has to be calibrated scale in order to accurately calculate the volume inside the tubular body) for the purpose of determining the fluid inside the tubular body (column 2, lines 43-47).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the tubular body of Kriesel to incorporate wherein the markings include a calibrated scale including graduated marks as taught by McNaughton for the purpose of determining the fluid inside the tubular body (column 2, lines 43-47).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Gray (US 2003/0139706 A1).
Regarding claim 25, Kriesel discloses the claimed invention substantially as claimed, as set forth above in claims 1, 22 and 24. Kriesel is silent regarding wherein at least an outer surface of the perimeter seal includes glass.
However, Gray teaches a design of a dispenser (figure 1) wherein at least on outer surface of the perimeter seal includes glass (paragraph 0084, entire piston and all other components of Gray’s dispenser can be made from glass, “glass materials”) for the purpose of using a well-known alternative material for designing perimeter seal (paragraph 0084).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of the outer surface of the perimeter seal of Kriesel to include glass as taught by Gray for the purpose of using a well-known alternative material for designing the perimeter seal (paragraph 0084).
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Cowan et al. (US 2013/0126559 A1).
Regarding claim 26, Kriesel discloses the claimed invention substantially as claimed, as set forth above in claims 1, 22 and 24. Kriesel is silent regarding wherein at an outer surface of the perimeter seal includes polytetrafluoroethylene (PTFE).
However, Cowan teaches a design of a dispenser (figure 1) wherein at an outer surface of the perimeter seal 22 includes polytetrafluoroethylene (PTFE) (paragraph 0034, lines 3-9) for the purpose of using a well0known alternative material to design the perimeter seal that provides appropriate sealing properties (paragraph 0034, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of an outer surface of the perimeter seal of Kriesel to incorporate polytetrafluoroethylene (PTFE) as taught by Cowan for the purpose of using a well0known alternative material to design the perimeter seal that provides appropriate sealing properties (paragraph 0034, lines 1-9).
Regarding claim 27, Kriesel discloses the claimed invention substantially as claimed, as set forth above in claims 1, 22 and 24. Kriesel is silent regarding wherein at an outer surface of the perimeter seal includes polytetrafluoroethylene (PTFE).
However, Cowan teaches a design of a dispenser (figure 1) wherein at an outer surface of the perimeter seal 22 includes polytetrafluoroethylene (PTFE) (paragraph 0034, lines 3-9) for the purpose of using a well-known alternative material to design the perimeter seal that provides appropriate sealing properties (paragraph 0034, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of an outer surface of the perimeter seal of Kriesel to incorporate polytetrafluoroethylene (PTFE) as taught by Cowan for the purpose of using a well-known alternative material to design the perimeter seal that provides appropriate sealing properties (paragraph 0034, lines 1-9).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Hamacher et al. (US 2005/0167267 A1).
Regarding claim 28, Kriesel discloses the claimed invention substantially as claimed, as set forth above in claims 1, 22 and 24. Kriesel is silent regarding wherein at least an outer surface of the perimeter seal includes polyether ether ketone (PEEK).
However, Hamacher teaches a design of a dispenser (figure 1) comprising wherein at least an outer surface of the perimeter seal includes polyether ether ketone (PEEK) (paragraph 0018, lines 2-4) for the purpose of designing a perimeter seal using a chemically inert material (paragraph 0018, lines 2-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of an outer surface of the perimeter seal of hamacher to incorporate polyether ether ketone as taught by Hamacher for the purpose of designing a perimeter seal using a chemically inert material (paragraph 0018, lines 2-4).
Claim(s) 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kriesel (US 5,569,236) in view of Montalvo (US 2016/0144102 A1).
Regarding claims 30 and 31, Kriesel discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 29. Kriesel is silent regarding wherein the cannula comprises a septum-sealed connector configured to prevent gas and/or micro- organisms from entering the cannula, wherein the septum-sealed connector comprises a first membrane and a second membrane separated by an air gap, wherein the first membrane is hydrophobic and the second membrane is hydrophilic.
However Montalvo teaches a design of a fluid conduit assembly wherein the cannula 908 (figure 6) comprises a septum-sealed connector (entire structure of element 900 shown in figure 6 except for elements 908 and 914) configured to prevent gas and/or micro-organisms from entering the cannula (paragraph 0041), wherein the septum-sealed connector comprises a first membrane 934 and a second membrane 924 separated by an air gap (gap between elements 924 and 934), wherein the first membrane 934 is hydrophobic (paragraph 0041, “hydrophobic properties”) and the second membrane 924 is hydrophilic (paragraph 0039, lines 1-6) for the purpose of removing air bubbles from the fluid prior to delivering the fluid to the patient (paragraph 0004, lines 1-5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the cannula of Kriesel to incorporate wherein the cannula comprises a septum-sealed connector configured to prevent gas and/or micro- organisms from entering the cannula, wherein the septum-sealed connector comprises a first membrane and a second membrane separated by an air gap, wherein the first membrane is hydrophobic and the second membrane is hydrophilic as taught by Montalvo for the purpose of removing air bubbles from the fluid prior to delivering the fluid to the patient (paragraph 0004, lines 1-5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783