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
It is noted that Applicant did not properly identify the amendments made to claim 19. In claim 19 “and a member outer surface having member forward and rearward engagement surfaces located proximal to respective forward and rearward ends of the member's respective forward and rearward portions” was added and not properly underlined as new. It is noted that all amendments should be properly identified. See 37 CFR 1.121, section (c)(2). Examiner notes although these amendments are not underlined, they are entered.
Applicant filed a supplemental response on 11/23/2025 in which additional arguments were presented. The specification amendments and claim amendments of 11/23/2025 are the same as what was filed on 11/19/2025. The arguments submitted on 11/23/2025 are addressed below.
Election/Restrictions
Applicant's election with traverse of group I and species A in the reply filed on 11/19/2025 and 11/23/2025 is acknowledged. The traversal is on the ground(s) that the restriction to a single group is not warranted and restriction to a single species is not warranted. Applicant argues that in view of the amendments made to claim 19, the process for using the product as claimed is not practiced with a materially different product. It is noted that claim 19 still does not require the forward and rearward engagement surfaces to each be configured for fluid tight engagement with the fluid circuit for fluid communication with the member lumen. Furthermore, it is noted that for a restriction between a product and process of use the inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. Applicant’s amendments to claim 19 still result in the product as claimed being able to be used in a materially different process of using that product. As at least one of (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product is shown, and a serious search burden exists, the restriction between inventions is proper. Applicant argues that the Examiner is reciting a false distinction in that the product as claimed can be used in a materially different process of using that product. Applicant states on page 10 of the arguments that “both the apparatus and method of the claimed invention may be used to infuse medications and/or fluids in a patient, as well as to remove blood samples”. Applicant further states that the claims do not distinguish between the capability of the apparatus or method in terms of infusion and blood sampling. Applicant’s arguments are not found to be persuasive as the method of invention II is not claimed as a method of infusion or blood sampling. The method of invention II, as claimed, is a method of accessing a fluid circuit. No where does the method of claim 19 claim that the method is for infusion or blood sampling. Therefore, as supported by the specification and structure of the product of claim 1, the product can be used in a different method than the claimed method of claim 19. Said differently, if the product is used in a method of infusion or blood sampling (which the specification and structure of the product supports), the product would be used in a different method than the method claimed in claim 19 as the claimed method of claim 19 is not a method of infusion or blood sampling. Applicant argues that “nowhere does the specification or claims distinguish between the capability of the apparatus or method in terms of infusion and blood sampling”. This argument is not found to be persuasive since the method as currently claimed is what is considered when evaluating if the product as claimed can be used in a materially different process of using that product is shown.
Applicant argues that the Examiner has failed to meet the burden supporting any restriction under MPEP 808.02 as the Examiner must explain why there would be a serious burden and must show by appropriate explanation…[the] separate classification thereof… that each invention has attained recognition in the art as a separate subject for invention effort, and also a separate field of search. It is noted that MPEP 808.02 states “In order to demonstrate a serious search burden, the examiner must show by appropriate explanation one of the following: (A) Separate classification thereof: This shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search. Patents need not be cited to show separate classification. (B) A separate status in the art when they are classifiable together: Even though they are classified together, each invention can be shown to have formed a separate subject for inventive effort when the examiner can show a recognition of separate inventive effort by inventors. Separate status in the art may be shown by citing patents which are evidence of such separate status, and also of a separate field of search. (C) A different field of search: Where it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries), a different field of search is shown, even though the two are classified together. The indicated different field of search must in fact be pertinent to the type of subject matter covered by the claims. Patents need not be cited to show different fields of search.” Applicant’s arguments are therefore not found to be persuasive as the Examiner did show by appropriate explanation at least one of the following listed in MPEP 808.02. Examiner clearly indicated in the restriction requirement that “The inventions have acquired a separate status in the art in view of their different classification and require a different field of search (E.G. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries); and/or prior art applicable to one group would not likely be applicable to another group”. As noted in MPEP 808.02, patents need not be cited to show different fields of search or cited to show separate classification.
Applicant further argues that the apparatus and method do not require different fields of search as a search in either cited class in the restriction would likely result in locating prior art pertinent to both groups I and II and searching different class/subclasses or electronic resources, or employing different search queries is not necessary. Examiner respectfully disagrees. Invention I does not require being positively used as claimed in the method. Search queries and prior art used for invention II would have to be tailored to specifically disclose the method and specific use of accessing a fluid circuit, whereas search queries and prior art used for invention I would not have to specifically state what is claimed in the method and would only need to have a claimed structure which is capable of performing a recited function. Furthermore, several claims in invention I (see for example claim 3-4 and 12-13) require additional limitations not required in invention II which would require searching different class/subclasses or electronic resources, or employing different search queries from invention II.
Applicant additionally argues that a search of the single class A61M39/00 should prove adequate in locating prior art for both groups I and II. Examiner respectfully disagrees. Searching in only A61M39/00 (tube couplings) would not necessarily yield at least one pump or at least one oxygenator. Additionally, Examiner respectfully disagrees that the search of only a single class is necessary to adequately cover all claimed subject matter as argued by Applicant, as several dependent claims in invention I would require a different search outside of A61M39/00 given the specific limitations regarding a fluid source and occlusion device for example.
In regard to the species election requirement, Applicant argues that claim 9 and 18 (species C) are not separate and distinct from claim 8 and 17 (species B). This argument is not found to be persuasive as Applicant has improperly characterized the species identified by the Examiner. MPEP 806.04(e) states “claims themselves are never species” and “Species always refer to the different embodiments of the invention”. Species B was indicated as figure 7-10, not claim 8 or 17 as argued by Applicant, and species C was indicated as figure 12-13, not claim 9 or 18 as argued by Applicant. As illustrated in figures 7-10 and 12-13 and described on page 21, line 4-6 and page 25, line 12-18, species B contains mutually exclusive characteristics from species C. There is a serious search burden for example since prior art applicable to at least one selectively occludable port and associated components unitary with the access vessel (species B) would likely not be applicable to the at least one selectively occludable port removably connected (species C). If the port was unitary, it would also not be removable. Page 21, line 4 also specifically states that “Referring to FIGS. 7 and 8, an alternate embodiment of the access vessel 55”. The species would also require a different field of search due to their mutually exclusive characteristics.
Applicant further argues that claims 3-6 and 12-16 (species A) are not separate and distinct from claims 8-9 and 17-18 (species B) because generic claims 1-2 and 10-11 together define an element common to each species. This argument is not found to be persuasive as Applicant has improperly characterized the species identified by the Examiner. MPEP 806.04(e) states “claims themselves are never species” and “Species always refer to the different embodiments of the invention”. Species A was identified as figure 2-6, not claims 3-6 and 12-16. Examiner agrees that the species share generic claims. However, the species also include mutually exclusive characteristics and there is a serious search burden which necessitate the species requirement. The fact that the species share generic claims does not preclude the Examiner from requiring a restriction between species. MPEP 806.04(d), cited by Applicant, defines the definition of a generic claim. MPEP 806.04(d) does not support the argument by Applicant that the presence of a generic claim results in the restriction being improper.
Applicant argues that the Examiner has failed to meet the burden of MPEP 808.02 in regard to the species requirement. As noted above, one of A B or C in MPEP 808.02 must be shown. Examiner stated that “There is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (E.G. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries); and/or prior art applicable to one group would not likely be applicable to another group”. The mutually exclusive characteristics would require a different filed of search. For example, as detailed above, prior art applicable to the at least one selectively occludable port and associated components unitary with the access vessel (species B) would likely not be applicable to the at least one selectively occludable port removably connected (species C). Prior art applicable to an occlusion device being a cap (species A) would also likely not be applicable to an occlusion device being a balloon. Applicant further states that “the Examiner has not showed, by appropriate explanation, how the purported species “are not obvious variants of each other”.” It is unclear if Applicant is suggesting on the record that the species are obvious variants of each other. It is noted that MPEP 808.02(A) does not require showing by appropriate explanation how the species are not obvious variants of each other. As stated in the restriction requirement, based on the current record, the species are not obvious variants of each other.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-9 and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim AND claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/19/2025 and 11/23/2025. Examiner notes although claims 11-14 also currently depend on claim 9, as detailed below this is construed as a mistake as claims 11-14 are drawn to the improved fluid circuit and claim 9 is drawn to the access vessel. Claims 11-14 are being examined and claim 11 is construed as depending on claim 10 as detailed below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/29/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
item 50
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “41” has been used to designate both an access cannula and flow in figure 1B. See figure 1B above. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
Line 1 recites “the infusion”. As the infusion has not been previously introduced, Examiner suggests replacing “the infusion” in line 1 with “an infusion”.
Line 2 recites “the removal”. As the removal has not been previously introduced, Examiner suggests replacing “the removal” in line 2 with “a removal”.
Line 3 recites “a patient”. As a patient is already stated in line 1, Examiner suggests replacing “a patient” in line 3 with “the patient” to put the abstract in clearer form.
Line 4 recites “a patient”. As a patient is already stated in line 1, Examiner suggests replacing “a patient” in line 4 with “the patient” to put the abstract in clearer form.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 objected to because of the following informalities:
Line 18 recites “said gateway outer end”. Line 18 also recites “an outer end of the gateway”. Examiner suggests replacing “said gateway outer end” in line 18 of claim 1 with “said outer end of said gateway” to put the claim in clearer form and more clearly refer to the outer end of the gateway of line 18.
Claim 2 objected to because of the following informalities:
Line 4-5 recites “the forward cylindrical inner surface”. Claim 2 depends on claim 1. Claim 1 recites “the forward inner cylindrical surface”. It appears a typo has been made. Examiner suggests replacing “the forward cylindrical inner surface” of line 4-5 of claim 2 with “the forward inner cylindrical surface” to put the claim in clearer form.
Line 5-6 recites “the medial inner cylindrical surface”. Claim 2 depends on claim 1. Claim 1 recites “the medial cylindrical inner surface”. It appears a typo has been made. Examiner suggests replacing “the medial inner cylindrical surface of line 5-6 of claim 2 with “the medial cylindrical inner surface” to put the claim in clearer form.
Line 6 recites “the member’s medial portion”. Examiner suggests replacing “the member’s medial portion” in line 6 of claim 2 with “the medial portion of the member” to put the claim in clearer form and clearly refer to the medial portion of claim 1.
Line 7-8 recites “the rearward cylindrical inner surface”. Line 2 of claim 2 recites “a rearward inner cylindrical surface”. It appears a typo has been made. Examiner suggests replacing “the rearward cylindrical inner surface” in line 7-8 of claim 2 with “the rearward inner cylindrical surface”.
Line 8 recites “the medial inner cylindrical surface”. Claim 2 depends on claim 1. Claim 1 recites “the medial cylindrical inner surface”. It appears a typo has been made. Examiner suggests replacing “the medial inner cylindrical surface of line 8 of claim 2 with “the medial cylindrical inner surface” to put the claim in clearer form.
Line 9 recites “the member’s medial portion”. Examiner suggests replacing “the member’s medial portion” in line 9 of claim 2 with “the medial portion of the member” to put the claim in clearer form and clearly refer to the medial portion of claim 1.
Claim 7 objected to because of the following informalities:
Line 1 recites “the reduction in diameter”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the reduction in diameter” in line 1 of claim 7 with “a reduction in diameter”.
Line 2 recites “the forward cylindrical inner surface”. Claim 7 depends on claim 6, claim 2 and claim 1. Claim 1 recites “the forward inner cylindrical surface”. It appears a typo has been made. Examiner suggests replacing “the forward cylindrical inner surface” of line 2 of claim 7 with “the forward inner cylindrical surface” to put the claim in clearer form.
Claim 10 objected to because of the following informalities:
Line 5 recites “the circuit”. Line 1 recites an improved fluid circuit and line 13 recites “the fluid circuit”. Examiner suggests replacing “the circuit” in line 5 of claim 10 with “the fluid circuit” to put the claim in clearer form and more clearly refer to the fluid circuit of line 1.
Line 19 recites “said gateway outer end”. Line 19 also recites “an outer end of the gateway”. Examiner suggests replacing “said gateway outer end” in line 19 of claim 10 with “said outer end of said gateway” to put the claim in clearer form and more clearly refer to the outer end of the gateway of line 19.
Claim 11 objected to because of the following informalities:
Examiner notes as detailed below, claim 11 is construed to be dependent on claim 10, not claim 9 for examination purposes.
Line 4-5 recites “the forward cylindrical inner surface”. Claim 11 depends on claim 10. Claim 10 recites “the forward inner cylindrical surface”. It appears a typo has been made. Examiner suggests replacing “the forward cylindrical inner surface” of line 4-5 of claim 11 with “the forward inner cylindrical surface” to put the claim in clearer form.
Line 5-6 recites “the medial inner cylindrical surface”. Claim 11 depends on claim 10. Claim 10 recites “the medial cylindrical inner surface”. It appears a typo has been made. Examiner suggests replacing “the medial inner cylindrical surface of line 5-6 of claim 11 with “the medial cylindrical inner surface” to put the claim in clearer form.
Line 6 recites “the member’s medial portion”. Examiner suggests replacing “the member’s medial portion” in line 6 of claim 11 with “the medial portion of the member” to put the claim in clearer form and clearly refer to the medial portion of claim 10.
Line 7-8 recites “the rearward cylindrical inner surface”. Line 2-3 of claim 11 recites “a rearward inner cylindrical surface”. It appears a typo has been made. Examiner suggests replacing “the rearward cylindrical inner surface” in line 7-8 of claim 11 with “the rearward inner cylindrical surface”.
Line 8-9 recites “the medial inner cylindrical surface”. Claim 11 depends on claim 10. Claim 10 recites “the medial cylindrical inner surface”. It appears a typo has been made. Examiner suggests replacing “the medial inner cylindrical surface of line 8-9 of claim 11 with “the medial cylindrical inner surface” to put the claim in clearer form.
Line 9 recites “the member’s medial portion”. Examiner suggests replacing “the member’s medial portion” in line 9 of claim 11 with “the medial portion of the member” to put the claim in clearer form and clearly refer to the medial portion of claim 10.
Claim 16 objected to because of the following informalities:
Line 1 recites “the reduction in diameter”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the reduction in diameter” in line 1 of claim 16 with “a reduction in diameter”.
Line 2 recites “the forward cylindrical inner surface”. Claim 16 depends on claim 15 and 10. Claim 10 recites “the forward inner cylindrical surface”. It appears a typo has been made. Examiner suggests replacing “the forward cylindrical inner surface” of line 2 of claim 16 with “the forward inner cylindrical surface” to put the claim in clearer form.
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 1-7 and 10-16 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.
In regard to claim 1,
Line 10-11 recites “a rearward engagement surface that the rearward end”. It is unclear what is meant by this. For examination purposes Examiner construes “a rearward engagement surface that the rearward end” to be “a rearward engagement surface at the rearward end”. Examiner suggests replacing “a rearward engagement surface that the rearward end” in line 10-11 of claim 1 with “a rearward engagement surface at the rearward end”.
Examiner notes claims 2-7 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 2,
Line 1-3 recites “wherein the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion”. It is unclear if the diameter of the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion or if a different component/property of the medical cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion. For examination purposes Examiner construes “wherein the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion” to be “wherein the diameter of the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion”. Examiner suggests replacing “wherein the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion” in line 1-3 of claim 2 with “wherein the diameter of the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion”.
Line 5-6 recites “the smaller diameter of the medial inner cylindrical surface”. Claim 2 depends on claim 1. Claim 1 recites “a medial cylindrical inner surface within the medical portion having a diameter that is smaller”. It is unclear if the smaller diameter of line 5-6 is the same diameter as in claim 1 or if the smaller diameter of line 5-6 is a different diameter. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the smaller diameter of the medial inner cylindrical surface” in line 5-6 of claim 2 with “the diameter of the medial cylindrical inner surface”.
Line 8 recites “the smaller diameter of the medial inner cylindrical surface”. Claim 2 depends on claim 1. Claim 1 recites “a medial cylindrical inner surface within the medical portion having a diameter that is smaller”. It is unclear if the smaller diameter of line 8 is the same diameter as in claim 1 or if the smaller diameter of line 8 is a different diameter. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the smaller diameter of the medial inner cylindrical surface” in line 8 of claim 2 with “the diameter of the medial cylindrical inner surface”.
Examiner notes claims 3-7 are similarly rejected by virtue of their dependency on claim 2.
In regard to claim 3,
Line 1 recites “the at least one input conduit”. There is insufficient antecedent basis for the limitation in this claim. Claim 3 depends on claim 2 and claim 1. Claim 1 recites “an input conduit”. It is unclear if the at least one input conduit is the same or different than the input conduit. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the at least one input conduit” in line 1 of claim 3 with “the input conduit”.
Line 3 recites “there-between”. It is unclear which structures “there-between” refers to as several structures/components have been introduced. As shown in figure 2 of the instant disclosure the at least one conduit is item 155. Based on figure 2, it appears the removable connection 198 is located between the conduit and the at least one gateway. Based on figure 2, it also appears the at least one gateway is in removable fluid communication with a fluid source via a removable connection. Examiner suggests clarifying what “there-between” refers to and clarifying that the at least one input conduit, not the at least one gateway is intended to be further defined in claim 3. For examination purposes Examiner construes “there-between” to be between two components of the access vessel.
Line 4 recites “an infusion pump”. Claim 3 depends on claim 2 and claim 1. Claim 1 recites “at least one pump”. It is unclear if the infusion pump is a pump of the at least one pump or if the infusion pump is in addition to the at least one pump. For examination purposes Examiner construes “an infusion pump” to be a pump of the at least one pump.
Line 1-4 recites “wherein the at least one input conduit is in removable fluid communication with a fluid source via a removable connection located there-between, the fluid source selected from a group consisting of a syringe, an IV drip container, and an infusion pump”. Claim 3 depends on claim 2 and claim 1. Claim 1 does not positively require the input conduit due to the language “operably engageable with an input conduit”. Claim 3 then further defines the at least one conduit and states that the at least one input conduit is in removable fluid communication. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). It is unclear if the at least one input conduit of claim 3 is positively required by the claim. For examination purposes Examiner construes the at least one input conduit to not be positively required by claim 3. Examiner suggests replacing “wherein the at least one input conduit is in removable fluid communication” in line 1-2 of claim 3 with “wherein the input conduit is configured to be in removable fluid communication”.
Examiner notes claim 5 is similarly rejected by virtue of its dependency on claim 3.
In regard to claim 4,
Line 1-2 recites “the at least one input conduit”. There is insufficient antecedent basis for the limitation in this claim. Claim 4 depends on claim 2 and claim 1. Claim 1 recites “an input conduit”. It is unclear if the at least one input conduit is the same or different than the input conduit. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the at least one input conduit” in line 1-2 of claim 4 with “the input conduit”.
Line 1-4 recites “wherein an outward flow of fluid through the at least one input conduit is prevented by an occlusion device via a removable connection located there-between, the occlusion device selected from a group consisting of an occlusion cap and an inwardly-biased one-way valve”. Claim 4 depends on claim 2 and claim 1. Claim 1 does not positively require the input conduit due to the language “operably engageable with an input conduit”. Claim 4 then further defines the at least one conduit and states that an outward flow of fluid through the at least one input conduit is prevented. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). It is unclear if the at least one input conduit of claim 4 is positively required by the claim. For examination purposes Examiner construes the at least one input conduit to not be positively required by claim 4. Examiner suggests replacing “wherein an outward flow of fluid through the at least one input conduit is prevented” in line 1-2 of claim 4 with “wherein an outward flow of fluid through the input conduit is configured to be prevented”.
Line 3 recites “there-between”. It is unclear which structures “there-between” refers to as several structures/components have been introduced. As shown in figure 2 of the instant disclosure the at least one conduit is item 155. Based on figure 2, it appears the removable connection 198 is located between the conduit and the at least one gateway. Based on figure 2, it also appears an outward fluid flow of fluid through the at least one gateway is prevented by an occlusion device. Examiner suggests clarifying what “there-between” refers to and clarifying that the at least one input conduit, not the at least one gateway is intended to be further defined in claim 4. For examination purposes Examiner construes “there-between” to be between two components of the access vessel.
Examiner notes claim 5 is similarly rejected by virtue of its dependency on claim 4.
In regard to claim 6,
Line 1-2 recites “wherein a fluid flow through the member lumen is about equal to a fluid flow through the at least one pump”. It is unclear due to the positive recitation of “is about equal” if a method step is being claimed. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “wherein a fluid flow through the member lumen is about equal to a fluid flow through the at least one pump” to be “wherein a fluid flow through the member lumen is configured to be about equal to a fluid flow through the at least one pump”. Examiner also notes the fluid has not been positively required by the claim and it is unclear if claim 6 is attempting to positively require the fluid.
Examiner notes claim 7 is similarly rejected by virtue of its dependency on claim 6.
In regard to claim 10,
Line 1 recites “An improved fluid circuit of the type having at least one pump”. It is unclear due to the phrase “of the type” if the improved fluid circuit positively has the at least one pump and the at least one oxygenator or if the type is only required to have the at least one pump and the at least one oxygenator. For examination purposes Examiner construes the improved fluid circuit to have the at least one pump and the at least one oxygenator. Examiner suggests removing the term “of the type” from claim 10.
Line 4 recites “the improvement comprising”. There is insufficient antecedent basis for the improvement. It is unclear if the improvement is the same or different than the improved fluid circuit. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the improvement comprising” in line 4 of claim 10 with “the improved fluid circuit comprising”.
Line 5 recites “an access vessel in fluid communication with the circuit”. The access vessel is claimed as a component of the fluid circuit. It is unclear how the access vessel can be in communication with the circuit if the access vessel is a portion of the circuit. For examination purposes Examiner construes “an access vessel in fluid communication with the circuit” to be “an access vessel in fluid communication with a portion of the circuit”. Examiner suggests replacing “an access vessel in fluid communication with the circuit” in line 5 of claim 10 with “an access vessel in fluid communication with a portion of the fluid circuit”.
Line 11-12 recites “a rearward engagement surface that the rearward end”. It is unclear what is meant by this. For examination purposes Examiner construes “a rearward engagement surface that the rearward end” to be “a rearward engagement surface at the rearward end”. Examiner suggests replacing “a rearward engagement surface that the rearward end” in line 11-12 of claim 10 with “a rearward engagement surface at the rearward end”.
Line 12-13 recites “the forward and rearward engagement surfaces each configured for fluid- tight engagement with the fluid circuit”. The forward and rearward engagement surfaces are claimed as components of the fluid circuit. It is unclear how the forward and rearward engagement surfaces are configured for fluid-tight engagement with the fluid circuit since the forward and rearward engagement surfaces are components of the fluid circuit. For examination purposes Examiner construes “the forward and rearward engagement surfaces each configured for fluid- tight engagement with the fluid circuit” to be “the forward and rearward engagement surfaces each configured for fluid- tight engagement with a portion of the fluid circuit”. Examiner suggests replacing “the forward and rearward engagement surfaces each configured for fluid- tight engagement with the fluid circuit” in line 12-13 of claim 10 with “the forward and rearward engagement surfaces each configured for fluid- tight engagement with a portion of the fluid circuit”.
In regard to claim 11,
Examiner notes as detailed below, claim 11 is construed to be dependent on claim 10, not claim 9 for examination purposes.
Line 1-3 recites “wherein the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion”. It is unclear if the diameter of the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion or if a different component/property of the medical cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion. For examination purposes Examiner construes “wherein the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion” to be “wherein the diameter of the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion”. Examiner suggests replacing “wherein the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion” in line 1-3 of claim 11 with “wherein the diameter of the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface defined within the rearward portion”.
Line 5-6 recites “the smaller diameter of the medial inner cylindrical surface”. Claim 11 depends on claim 10. Claim 10 recites “a medial cylindrical inner surface within the medical portion having a diameter that is smaller”. It is unclear if the smaller diameter of line 5-6 is the same diameter as in claim 10 or if the smaller diameter of line 5-6 is a different diameter. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the smaller diameter of the medial inner cylindrical surface” in line 5-6 of claim 11 with “the diameter of the medial cylindrical inner surface”.
Line 8-9 recites “the smaller diameter of the medial inner cylindrical surface”. Claim 11 depends on claim 10. Claim 10 recites “a medial cylindrical inner surface within the medical portion having a diameter that is smaller”. It is unclear if the smaller diameter of line 8-9 is the same diameter as in claim 10 or if the smaller diameter of line 8-9 is a different diameter. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the smaller diameter of the medial inner cylindrical surface” in line 8-9 of claim 11 with “the diameter of the medial cylindrical inner surface”.
Examiner notes claims 12-14 are similarly rejected by virtue of their dependency on claim 11.
In regard to claim 12,
Line 1-2 recites “the at least one input conduit”. There is insufficient antecedent basis for the limitation in this claim. Claim 12 depends on claim 11 and claim 10. Claim 10 recites “an input conduit”. It is unclear if the at least one input conduit is the same or different than the input conduit. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the at least one input conduit” in line 1-2 of claim 12 with “the input conduit”.
Line 3 recites “there-between”. It is unclear which structures “there-between” refers to as several structures/components have been introduced. As shown in figure 2 of the instant disclosure the at least one conduit is item 155. Based on figure 2, it appears the removable connection 198 is located between the conduit and the at least one gateway. Based on figure 2, it also appears the at least one gateway is in removable fluid communication with a fluid source via a removable connection. Examiner suggests clarifying what “there-between” refers to and clarifying that the at least one input conduit, not the at least one gateway is intended to be further defined in claim 12. For examination purposes Examiner construes “there-between” to be between two components of the fluid circuit.
Line 4 recites “an infusion pump”. Claim 12 depends on claim 11 and claim 10. Claim 10 recites “at least one pump”. It is unclear if the infusion pump is a pump of the at least one pump or if the infusion pump is in addition to the at least one pump. For examination purposes Examiner construes “an infusion pump” to be a pump of the at least one pump.
Line 1-4 recites “wherein the at least one input conduit is in removable fluid communication with a fluid source via a removable connection located there-between, the fluid source selected from a group consisting of a syringe, an IV drip container, and an infusion pump”. Claim 12 depends on claim 11 and claim 10. Claim 10 does not positively require the input conduit due to the language “operably engageable with an input conduit”. Claim 12 then further defines the at least one conduit and states that the at least one input conduit is in removable fluid communication. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). It is unclear if the at least one input conduit of claim 12 is positively required by the claim. For examination purposes Examiner construes the at least one input conduit to not be positively required by claim 12. Examiner suggests replacing “wherein the at least one input conduit is in removable fluid communication” in line 1-2 of claim 12 with “wherein the input conduit is configured to be in removable fluid communication”.
Examiner notes claim 14 is similarly rejected by virtue of its dependency on claim 12.
In regard to claim 13,
Line 2 recites “the at least one input conduit”. There is insufficient antecedent basis for the limitation in this claim. Claim 13 depends on claim 11 and claim 10. Claim 10 recites “an input conduit”. It is unclear if the at least one input conduit is the same or different than the input conduit. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the at least one input conduit” in line 2 of claim 13 with “the input conduit”.
Line 1-4 recites “wherein an outward flow of fluid through the at least one input conduit is prevented by an occlusion device via a removable connection located there-between, the occlusion device selected from a group consisting of an occlusion cap and an inwardly-biased one-way valve”. Claim 13 depends on claim 11 and claim 10. Claim 10 does not positively require the input conduit due to the language “operably engageable with an input conduit”. Claim 13 then further defines the at least one conduit and states that an outward flow of fluid through the at least one input conduit is prevented. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). It is unclear if the at least one input conduit of claim 13 is positively required by the claim. For examination purposes Examiner construes the at least one input conduit to not be positively required by claim 13. Examiner suggests replacing “wherein an outward flow of fluid through the at least one input conduit is prevented” in line 1-2 of claim 13 with “wherein an outward flow of fluid through the input conduit is configured to be prevented”.
Line 3 recites “there-between”. It is unclear which structures “there-between” refers to as several structures/components have been introduced. As shown in figure 2 of the instant disclosure the at least one conduit is item 155. Based on figure 2, it appears the removable connection 198 is located between the conduit and the at least one gateway. Based on figure 2, it also appears an outward fluid flow of fluid through the at least one gateway is prevented by an occlusion device. Examiner suggests clarifying what “there-between” refers to and clarifying that the at least one input conduit, not the at least one gateway is intended to be further defined in claim 13. For examination purposes Examiner construes “there-between” to be between two components of the fluid circuit.
Examiner notes claim 14 is similarly rejected by virtue of its dependency on claim 13.
In regard to claim 15,
Line 1-2 recites “wherein a fluid flow through the member lumen is about equal to a fluid flow through the at least one pump”. It is unclear due to the positive recitation of “is about equal” if a method step is being claimed. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “wherein a fluid flow through the member lumen is about equal to a fluid flow through the at least one pump” to be “wherein a fluid flow through the member lumen is configured to be about equal to a fluid flow through the at least one pump”. Examiner also notes the fluid has not been positively required by the claim and it is unclear if claim 15 is attempting to positively require the fluid.
Examiner notes claim 16 is similarly rejected by virtue of its dependency on claim 15.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11-14 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regard to claim 11,
Line 1 recites “The improved circuit of claim 9”. Claim 9 is drawn to an access vessel, not an improved circuit. Claim 9 is also dependent on claim 2 which recites the same limitations as claim 11. For examination purposes Examiner construes claim 11 to be dependent on claim 10, which is drawn to an improved circuit. Examiner suggests amending claim 11 to be dependent on claim 10.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 10, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Katsuno (U.S. PG publication 20060284423).
In regard to claim 1,
Katsuno discloses an access vessel (see figure 5A and 5B, item 40) for use in a fluid circuit (see fluid circuit shown in figure 3) having at least one pump (figure 3, item 2 and 8A) configured for fluid communication with a patient, and at least one oxygenator (figure 2, item 1) in fluid communication with the at least one pump (see figure 3) and configured for fluid communication with the patient (Examiner notes “for use in a fluid circuit having at least one pump configured for fluid communication with a patient, and at least one oxygenator in fluid communication with the at least one pump and configured for fluid communication with the patient” is a functional limitation. The fluid circuit, at least one pump, and the at least one oxygenator are not positively required by the claim. The access vessel is fully capable of the recited function due to its structure), the access vessel comprising:
an axial member defining forward (figure 5A and 5B, item 41), medial (figure 5A and 5B, item 43A) and rearward portions (figure 5A and 5B, item 42) and an interior member lumen (see opening through item 41, 43A and 42 which forms a lumen), said member lumen extending through the forward, medial and rearward portions of the member (see figure 5B) and defining a forward opening (opening of item 41) at a forward end of the forward portion (see figure 5B) and a rearward opening (opening of item 42) at a rearward end of the rearward portion (see figure 5B);
an outer surface defined by the member (see figure 5A and 5B), said outer surface defining a forward engagement surface at the forward end (see figure 5B) and a rearward engagement surface that the rearward end (see figure 5B), the forward and rearward engagement surfaces each configured for fluid-tight engagement with the fluid circuit for fluid communication with the member lumen (Examiner notes “configured for fluid-tight engagement with the fluid circuit for fluid communication with the member lumen” is a functional limitation. The fluid circuit is not positively required by the claim. The forward and rearward engagement surfaces are fully capable due to their structure of fluid-tight engagement with an appropriately sized fluid circuit for fluid communication with the member lumen), the member lumen defining a medial cylindrical inner surface (see inner surface of item 43A in figure 5B) within the medial portion (see figure 5B) having a diameter that is smaller than at least a diameter of a forward inner cylindrical surface (see inner surface of item 41) defined within the forward portion (see figure 5B);
at least one gateway (figure 5a and 5B, item 44) defining a gateway lumen (see lumen of item 44 shown in figure 5B) through the medial portion of the member (see figure 5B) in fluid communication with the member lumen (see figure 5B), said gateway lumen further defining a gateway opening at an outer end of the gateway (see figure 5B wherein the opening of item 44 is the gateway opening), said gateway outer end operably engageable with an input conduit for fluid communication with the gateway lumen (Examiner notes “operably engageable with an input conduit for fluid communication with the gateway lumen” is a functional limitation. The input conduit is not positively required by the claim. The gateway outer end is fully capable of engaging an appropriately sized input conduit for fluid communication with the gateway lumen due to its structure; paragraph [0100]).
In regard to claim 10,
Katsuno discloses an improved fluid circuit (see all of figure 3) of the type having at least one pump (figure 3, item 2 and 8A) configured for fluid communication with a patient (Examiner notes “configured for fluid communication with a patient” is a functional limitation. Due to the structure of the at least one pump, it is fully capable of the recited function), and at least one oxygenator (figure 1, item 1) in fluid communication with the at least one pump (see figure 3) and configured for fluid communication with the patient (Examiner notes “configured for fluid communication with a patient” is a functional limitation. Due to the structure of the at least one oxygenator, it is fully capable of the recited function), the improvement comprising:
an access vessel (see figure 5A and 5B, item 40) in fluid communication with the circuit (see figure 3; paragraph [0100] and [0050]), the access vessel comprising an axial member defining forward (figure 5A and 5B, item 41), medial (figure 5A and 5B, item 43A) and rearward portions (figure 5A and 5B, item 42) and an interior member lumen (see opening through item 41, 43A and 42 which forms a lumen), said member lumen extending through the forward, medial and rearward portions of the member (see figure 5B) and defining a forward opening (opening of item 41) at a forward end of the forward portion (see figure 5B) and a rearward opening (opening of item 42) at a rearward end of the rearward portion (see figure 5B);
an outer surface defined by the member (see figure 5A and 5B), said outer surface defining a forward engagement surface at the forward end (see figure 5B) and a rearward engagement surface that the rearward end (see figure 5B), the forward and rearward engagement surfaces each configured for fluid-tight engagement with the fluid circuit for fluid communication with the member lumen (Examiner notes “configured for fluid-tight engagement with the fluid circuit for fluid communication with the member lumen” is a functional limitation. The forward and rearward engagement surfaces are fully capable due to their structure of fluid-tight engagement with the fluid circuit for fluid communication with the member lumen), the member lumen defining a medial cylindrical inner surface (see inner surface of item 43A in figure 5B) within the medial portion (see figure 5B) having a diameter that is smaller than at least a diameter of a forward inner cylindrical surface (see inner surface of item 41) defined within the forward portion (see figure 5B);
at least one gateway (figure 5a and 5B, item 44) defining a gateway lumen (see lumen of item 44 shown in figure 5B) through the medial portion of the member (see figure 5B) in fluid communication with the member lumen (see figure 5B), said gateway lumen further defining a gateway opening at an outer end of the gateway (see figure 5B wherein the opening of item 44 is the gateway opening), said gateway outer end operably engageable with an input conduit for fluid communication with the gateway lumen (Examiner notes “operably engageable with an input conduit for fluid communication with the gateway lumen” is a functional limitation. The input conduit is not positively required by the claim. The gateway outer end is fully capable of engaging an appropriately sized input conduit for fluid communication with the gateway lumen due to its structure; paragraph [0100]).
In regard to claim 15,
Katsuno discloses the improved fluid circuit of claim 10 wherein a fluid flow through the member lumen is about equal to a fluid flow through the at least one pump (Examiner notes the fluid is not positively required by the claim. Claim 15 is also not a method claim. The claim also does not specify what portion of the member lumen a fluid flow through the member lumen is about equal to a fluid flow through the at least one pump. Due to the structure of the member lumen and the structure of the at least one pump, a fluid flow through the member lumen is fully capable of being about equal to a fluid flow through the at least one pump. The term “about” is also not further defined and therefore some deviation of fluid flow is allowed. Additionally, the claim does not specify whether the velocity, volume, or pressure or other property of a fluid flow through the member lumen is about equal to a fluid flow through the at least one pump).
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.
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 2-3, 6-7, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Katsuno (U.S. PG publication 20060284423) and further in view of Rhode (U.S. PG publication 20190021945).
In regard to claim 2,
Katsuno discloses the access vessel of claim 1 wherein the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface (see inner surface of item 40) defined within the rearward portion (see figure 5B).
Katsuno fails to disclose the member lumen further defining a forward frusto-conical transition surface located rearwardly of the forward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface of the member's medial portion and the member lumen further defining a rearward frusto-conical transition surface located forwardly of the rearward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface of the member's medial portion.
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Rhode teaches the member lumen (see lumen of item 6 in figure 3B) further defining a forward frusto-conical transition surface (see figure 3B above) located rearwardly of the forward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface (see figure 3B above) of the member's medial portion (see figure 3B) and the member lumen further defining a rearward frusto-conical transition surface (see figure 3B above) located forwardly of the rearward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface of the member's medial portion (see figure 3B above).
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 Katsuno to include the member lumen further defining a forward frusto-conical transition surface located rearwardly of the forward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface of the member's medial portion and the member lumen further defining a rearward frusto-conical transition surface located forwardly of the rearward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface of the member's medial portion, as taught by Rhode, for the purpose of providing a suction effect and an increased emptying rate (paragraph [0049], [0048], and [0025] of Rhode).
In regard to claim 3,
Katsuno in view of Rhode teaches the access vessel of claim 2 wherein the at least one input conduit is in removable fluid communication with a fluid source (see figure 3, item 2 of Katsuno; See 112 rejection above for claim interpretation) via a removable connection located there-between (see figure 3 of Katsuno wherein the removable connection is construed as connector H in figure 3 of Katsuno), the fluid source selected from a group consisting of a syringe, an IV drip container, and an infusion pump (infusion pump, see item 2 of figure 3 of Katsuno).
In regard to claim 6,
Katsuno in view of Rhode teaches the access vessel of claim 2 wherein a fluid flow rate through the member lumen is about equal to a fluid flow rate generated by the at least one pump (Examiner notes the fluid and the at least one pump is not positively required by the claim. Claim 6 is also not a method claim. The claim also does not specify what portion of the member lumen a fluid flow through the member lumen is about equal to a fluid flow through the at least one pump. Due to the structure of the member lumen, a fluid flow through the member lumen is fully capable of being about equal to a fluid flow through an appropriate at least one pump. The term “about” is also not further defined and therefore some deviation of fluid flow is allowed. Additionally, the claim does not specify whether the velocity, volume, or pressure or other property of a fluid flow through the member lumen is about equal to a fluid flow through the at least one pump).
In regard to claim 7,
Katsuno in view of Rhode teaches the access vessel of claim 6 wherein the reduction in diameter of the medial cylindrical inner surface from the forward cylindrical inner surface defines a percentage reduction (see figure 5B of Katsuno).
Katsuno in view of Rhode is silent as to a percentage reduction selected from a group consisting of about 25 percent and about 50 percent.
It would have been an obvious matter of design choice to modify Katsuno in view of Rhode to include a percentage reduction selected from a group consisting of about 25 percent and about 50 percent since applicant has not disclosed that having a percentage reduction selected from a group consisting of about 25 percent and about 50 percent solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of a percentage reduction selected from a group consisting of about 25 percent and about 50 percent, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Examiner notes page 18, line 5-8 of the instant disclosure supports that other reductions between about 1% and 99% are also possible.
In regard to claim 11,
Katsuno discloses the improved fluid circuit of claim 9 (see 112 rejection above where claim 11 is construed to be dependent on claim 10, not claim 9) wherein the medial cylindrical inner surface within the medial portion is smaller than a diameter of a rearward inner cylindrical surface (see inner surface of item 40) defined within the rearward portion (see figure 5B).
Katsuno fails to disclose the member lumen further defining a forward frusto-conical transition surface located rearwardly of the forward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface of the member's medial portion, the member lumen further defining a rearward frusto-conical transition surface located forwardly of the rearward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface of the member's medial portion.
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Rhode teaches the member lumen (see lumen of item 6 in figure 3B) further defining a forward frusto-conical transition surface (see figure 3B above) located rearwardly of the forward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface (see figure 3B above) of the member's medial portion (see figure 3B), the member lumen further defining a rearward frusto-conical transition surface (see figure 3B above) located forwardly of the rearward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface of the member's medial portion (see figure 3B above).
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 Katsuno to include the member lumen further defining a forward frusto-conical transition surface located rearwardly of the forward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface of the member's medial portion, the member lumen further defining a rearward frusto-conical transition surface located forwardly of the rearward cylindrical inner surface that transitions to the smaller diameter of the medial inner cylindrical surface of the member's medial portion, as taught by Rhode, for the purpose of providing a suction effect and an increased emptying rate (paragraph [0049], [0048], and [0025] of Rhode).
In regard to claim 12,
Katsuno in view of Rhode teaches the improved fluid circuit of claim 11 wherein the at least one input conduit is in removable fluid communication with a fluid source (see figure 3, item 2 of Katsuno; See 112 rejection above for claim interpretation) via a removable connection located there-between (see figure 3 of Katsuno wherein the removable connection is construed as connector H in figure 3 of Katsuno), the fluid source selected from a group consisting of a syringe, an IV drip container, and an infusion pump (infusion pump, see item 2 of figure 3 of Katsuno).
Claims 4-5 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Katsuno (U.S. PG publication 20060284423) in view of Rhode (U.S. PG publication 20190021945), and further in view of Kaczorowski (U.S. PG publication 20170120034).
In regard to claim 4,
Katsuno in view of Rhode teaches the access vessel of claim 2.
Katsuno in view of Rhode fails to disclose as to wherein an outward flow of fluid through the at least one input conduit is prevented by an occlusion device via a removable connection located there-between, the occlusion device selected from a group consisting of an occlusion cap and an inwardly-biased one-way valve.
Kaczorowski teaches wherein an outward flow of fluid through the at least one input conduit (input conduit that can be attached to item 26 of gateway item 25 in figure 7) is prevented by an occlusion device (see all of figure 8 which shows the occlusion device and see also figure 11 wherein the occlusion device is within item 25 and an outward flow of fluid into item 27 is therefore prevented from the input conduit as the occlusion device blocks item 25), via a removable connection (luer threads of item 43; paragraph [0076]; Examiner notes the connection is construed as a removable connection as it can be removed from item 25) located there-between (see figure 11 and 112 rejection above), the occlusion device selected from a group consisting of an occlusion cap and an inwardly-biased one-way valve (occlusion cap, see figure 8).
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 item 44 of Katsuno to include a component to engage with an occlusion device and removable connection as taught by Kaczorowski and to also include an occlusion device and removable connection as taught by Kaczorowski and to modify the input conduit accordingly, therefore resulting in wherein an outward flow of fluid through the at least one input conduit is prevented by an occlusion device via a removable connection located there-between, the occlusion device selected from a group consisting of an occlusion cap and an inwardly-biased one-way valve for the purpose of blocking access to a side port when not needed (paragraph [0071] of Kaczorowski).
In regard to claim 5,
Examiner notes claim 5 is construed as being dependent on claim 4.
Katsuno in view of Rhode in view of Kaczorowski teaches the access vessel of claims 3 or 4 wherein the removable connection comprises a Luer lock (see analysis of claim 4 above).
In regard to claim 13,
Katsuno in view of Rhode teaches the improved fluid circuit of claim 11.
Katsuno in view of Rhode fails to disclose wherein an outward flow of fluid through the at least one input conduit is prevented by an occlusion device via a removable connection located there-between, the occlusion device selected from a group consisting of an occlusion cap and an inwardly-biased one-way valve.
Kaczorowski teaches wherein an outward flow of fluid through the at least one input conduit (input conduit that can be attached to item 26 of gateway item 25 in figure 7) is prevented by an occlusion device (see all of figure 8 which shows the occlusion device and see also figure 11 wherein the occlusion device is within item 25 and an outward flow of fluid into item 27 is therefore prevented from the input conduit as the occlusion device blocks item 25), via a removable connection (luer threads of item 43; paragraph [0076]; Examiner notes the connection is construed as a removable connection as it can be removed from item 25) located there-between (see figure 11 and 112 rejection above), the occlusion device selected from a group consisting of an occlusion cap and an inwardly-biased one-way valve (occlusion cap, see figure 8).
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 item 44 of Katsuno to include a component to engage with an occlusion device and removable connection as taught by Kaczorowski and to also include an occlusion device and removable connection as taught by Kaczorowski and to modify the input conduit accordingly, therefore resulting in wherein an outward flow of fluid through the at least one input conduit is prevented by an occlusion device via a removable connection located there-between, the occlusion device selected from a group consisting of an occlusion cap and an inwardly-biased one-way valve for the purpose of blocking access to a side port when not needed (paragraph [0071] of Kaczorowski).
In regard to claim 14,
Examiner notes claim 14 is construed as being dependent on claim 13.
Katsuno in view of Rhode in view of Kaczorowski teaches the improved fluid circuit of claims 12 or 13 wherein the removable connection comprises a Luer lock (see analysis of claim 13 above).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Katsuno (U.S. PG publication 20060284423).
In regard to claim 16,
Katsuno discloses the improved fluid circuit of claim 15 wherein the reduction in diameter of the medial cylindrical inner surface from the forward cylindrical inner surface defines a percentage reduction (see figure 5B).
Katsuno is silent as to a percentage reduction selected from a group consisting of about 25 percent and about 50 percent.
It would have been an obvious matter of design choice to modify Katsuno to include a percentage reduction selected from a group consisting of about 25 percent and about 50 percent since applicant has not disclosed that having a percentage reduction selected from a group consisting of about 25 percent and about 50 percent solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of a percentage reduction selected from a group consisting of about 25 percent and about 50 percent, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Examiner notes page 18, line 5-8 of the instant disclosure supports that other reductions between about 1% and 99% are also possible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Calderon (U.S. PG publication 20050010077) discloses an access vessel (see figure 1) with at least one gateway (see item 55 in figure 2A).
Janik (U.S. PG publication 20220133975) discloses an access vessel (see figure 2, item 10) comprising a forward frusto-conical transition surface (see surface of item 10A) and a rearward frusto-conical transition surface (see surface of item 10C).
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.
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, 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 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783