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 .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 08/10/2026 is acknowledged.
Claims 16-19 & 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/10/2026.
Applicant's election with traverse of Species I in the reply filed on 08/10/2026 is acknowledged. The traversal is on the ground(s) that Species I and Species II are the same species. This is found persuasive because instant application Figure 1 shows each of the components in Species II. As such, Examiner will treat Applicant’s election as electing Species I, which is shown in Figures 1-11. However, Species III is still considered a distinct species.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are as follows,
“engaging elements” in Claim 2, where the generic placeholder is “elements”, the functional language is either “engaging” or “configured to couple said first injectable material transfer device and said second injectable material transfer device by relative axial and/or rotational movements of said first injectable material transfer device and said second injectable material transfer device, with the guidance of said first nozzle pocket”, and sufficient modifying structure is not provided; instant application Paragraphs 0081/0098 describes the engaging elements as Elements 224/324, and instant application Figure 2 shows Element 224 as a helical groove, and instant application Figure 8A shows Element 324 as protrusions, providing sufficient modifying structure
“biasing element” in Claim 3, where the generic placeholder is “element”, the functional language is either “biasing” or “to bias said first injectable material transfer device and said second injectable material transfer device with respect to each other to lock said engaging elements of said first injectable material transfer device and said second injectable material transfer device with respect to each other”, and sufficient modifying structure is not provided; the instant application does not describe the biasing element, so does not provide sufficient modifying structure – see 112(a) below for clarification
“engaging elements” in Claim 4, where the generic placeholder is “elements”, the functional language is either “engaging” or “to engage engaging elements of said first injectable material transfer device”, and sufficient modifying structure is not provided; instant application Paragraph 0081 describes the engaging elements as Element 254, and instant application Figure 2 shows Element 254 as a protrusion, providing sufficient modifying structure
“engaging elements” in Claims 6-7, where the generic placeholder is “elements”, the functional language is either “engaging” or “to engage engaging elements of said first injectable material transfer device”, and sufficient modifying structure is not provided; instant application Paragraph 00112 describes the engaging elements as Element 424, and instant application Figure 12 shows Element 424 as a helical groove, providing sufficient modifying structure
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to Claim 3, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a biasing element positioned between said first injectable material transfer device and said second injectable material transfer device to bias said first injectable material transfer device and said second injectable material transfer device with respect to each other to lock said engaging elements of said first injectable material transfer device and said second injectable material transfer device with respect to each other. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately describe the biasing element.
A biasing element is described in the original disclosure. However, the original disclosure fails to link any structure to the claimed biasing element. Instant application Paragraphs 0089/00100 describe the sue of seals as being used to bias structure. However, it would not be inherently clear to one of ordinary skill in the art if the seals are the structure intended to be the claimed biasing element. As such, the original disclosure fails to provide sufficient written support for the claimed biasing element.
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 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to Claim 1, the term “a first injectable material transfer device”, in Line 4, is indefinite. A first injectable material transfer device was defined in Line 2. As such, it is not clear if the first injectable material transfer device in Line 4 is the same first injectable material transfer device in Line 2, or if the respective devices are different from each other. For the purpose of examination, the first injectable material transfer device in Line 4 will be interpreted as the same first injectable material transfer device in Line 2.
The term “a second injectable material transfer device”, in Line 5, is indefinite. A second injectable material transfer device was defined in Line 2. As such, it is not clear if the second injectable material transfer device in Line 5 is the same second injectable material transfer device in Line 2, or if the respective devices are different from each other. For the purpose of examination, the second injectable material transfer device in Line 4 will be interpreted as the same second injectable material transfer device in Line 2.
The term “generally axially”, in Line 9, is indefinite. The bounds of the term “generally” are not clear, since it is not clear what would be considered “generally axially” or what would not be considered “generally axially”, rendering the claim indefinite. Applicant may overcome this rejection by replacing the term “generally” with “substantially”.
The limitation “are rotated with respect to each other”, in Line 9, is indefinite. It is not clear which structure is being referred to with the phrase “each other”, since multiple structures have been previously described, rendering the claim indefinite. For the purpose of examination, the structure associated with the phrase “each other” will be interpreted as the first and second injectable material transfer devices.
The term “said second injectable material transfer”, in Line 11, should read --said second injectable material transfer device.
As to Claim 3, the term “biasing element”, and the subsequent structure, is indefinite. As described in the 112(a) rejection above, the biasing element does not have sufficient written description in the original disclosure. As such, it is not clear how the biasing element is able to bias anything in general, or specifically, bias said first injectable material transfer device and said second injectable material transfer device with respect to each other to lock said engaging elements of said first injectable material transfer device and said second injectable material transfer device with respect to each other, rendering the claim indefinite.
As to Claim 4, the limitation “a third injectable material transfer device having engaging elements configured to be similar to engaging elements of said second injectable material transfer device to engage engaging elements of said first injectable material transfer device” is indefinite.
The use of the phrase “similar to” renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "similar to"), thereby rendering the scope of the claim unascertainable. Additionally, the bounds of the phrase are not clear, since it is not clear what other structures would be considered “similar to” the claimed engaging elements, and which structures would not be considered “similar to” the claimed engaging elements. See MPEP §2173.05(d).
The phrase “engaging elements of said first injectable material transfer device” is indefinite. Claim 1 previously defined “engaging elements of said first injectable material transfer device”. As such, it is not clear if the engaging elements of said first injectable material transfer device in Claim 4 are the same engaging elements of said first injectable material transfer device in Claim 1 or if the respective engaging elements are different from each other. For the purpose or examination, the respective engaging element will be interpreted as the same engaging elements of said first injectable material transfer device.
As to Claim 5, the term “generally axially”, in Line 9, is indefinite. The bounds of the term “generally” are not clear, since it is not clear what would be considered “generally axially” or what would not be considered “generally axially”, rendering the claim indefinite. Applicant may overcome this rejection by replacing the term “generally” with “substantially”.
As to Claim 6, the limitation “a fourth injectable material transfer device having engaging elements configured to be similar to engaging elements of said first injectable material transfer device to engage engaging elements of said second injectable material transfer device” is indefinite.
The use of the phrase “similar to” renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "similar to"), thereby rendering the scope of the claim unascertainable. Additionally, the bounds of the phrase are not clear, since it is not clear what other structures would be considered “similar to” the claimed engaging elements, and which structures would not be considered “similar to” the claimed engaging elements. See MPEP §2173.05(d).
The phrase “engaging elements of said second injectable material transfer device” is indefinite. Claim 1 previously defined “engaging elements of said second injectable material transfer device”. As such, it is not clear if the engaging elements of said second injectable material transfer device in Claim 6 are the same engaging elements of said second injectable material transfer device in Claim 1 or if the respective engaging elements are different from each other. For the purpose or examination, the respective engaging element will be interpreted as the same engaging elements of said second injectable material transfer device.
As to Claim 7, the limitation “a fourth injectable material transfer device having engaging elements configured to be similar to engaging elements of said first injectable material transfer device to engage engaging elements of said second injectable material transfer device” is indefinite.
The use of the phrase “similar to” renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "similar to"), thereby rendering the scope of the claim unascertainable. Additionally, the bounds of the phrase are not clear, since it is not clear what other structures would be considered “similar to” the claimed engaging elements, and which structures would not be considered “similar to” the claimed engaging elements. See MPEP §2173.05(d).
The phrase “engaging elements of said second injectable material transfer device” is indefinite. Claim 1 previously defined “engaging elements of said second injectable material transfer device”. As such, it is not clear if the engaging elements of said second injectable material transfer device in Claim 7 are the same engaging elements of said second injectable material transfer device in Claim 1 or if the respective engaging elements are different from each other. For the purpose or examination, the respective engaging element will be interpreted as the same engaging elements of said second injectable material transfer device.
As to Claim 8, the limitation “said first injectable material transfer device is selected from the group consisting of: a device defining a material chamber therein and having at least one nozzle through which material is ejected therefrom or aspirated therein…a device defining a nozzle port with respect to which a nozzle of another device may be seated in fluid communication therewith…an adaptor device or system coupling or facilitating coupling of a first device with at least one nozzle with a second device with at least one nozzle port” is indefinite.
The term “the group” lacks antecedent basis.
It is not clear if the claimed “at least one nozzle” is the same nozzle as the “first nozzle” defined in Claim 1, or if the respective nozzles are different nozzles. For the purpose of examination, the at least one nozzle and the first nozzle will be interpreted as the same structure.
It is not clear if the claimed “another device” is the same device as the “second injectable material device” defined in Claim 1, or if the respective devices are different devices.
It is not clear if the claimed “a first device” in the phrase “an adaptor device or system coupling or facilitating coupling of a first device with at least one nozzle with a second device with at least one nozzle port” is the same as the first injectable material transfer device, or if the respective devices are different devices.
It is not clear if the claimed “at least one nozzle” in the phrase “an adaptor device or system coupling or facilitating coupling of a first device with at least one nozzle with a second device with at least one nozzle port” is the same nozzle as the “first nozzle” defined in Claim 1, or if the respective nozzles are different nozzles. For the purpose of examination, the at least one nozzle and the first nozzle will be interpreted as the same structure.
It is not clear if the claimed “second device” in the phrase “an adaptor device or system coupling or facilitating coupling of a first device with at least one nozzle with a second device with at least one nozzle port” is the same as the second injectable material transfer device in Claim 1, or if the respective devices are different devices. For the purpose of examination, the respective devices will be interpreted as the same structure.
It is not clear if the claimed “at least one nozzle port” in the phrase “an adaptor device or system coupling or facilitating coupling of a first device with at least one nozzle with a second device with at least one nozzle port” is the same as the first nozzle port in Claim 1, or if the respective ports are different ports. For the purpose of examination, the respective ports will be interpreted as the same structure.
As to Claim 10, the term “generally axially”, in Line 9, is indefinite. The bounds of the term “generally” are not clear, since it is not clear what would be considered “generally axially” or what would not be considered “generally axially”, rendering the claim indefinite. Applicant may overcome this rejection by replacing the term “generally” with “substantially”.
As to Claim 15, the term “generally axially”, in Line 9, is indefinite. The bounds of the term “generally” are not clear, since it is not clear what would be considered “generally axially” or what would not be considered “generally axially”, rendering the claim indefinite. Applicant may overcome this rejection by replacing the term “generally” with “substantially”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 & 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greter (U.S. PGPub 2015/0190770). Note parallel rejection below for Claim 1.
As to Claim 1, Greter teaches an injectable material delivery system (1) configured to establish fluid communication between first (2) and second (5) injectable material transfer devices thereof, said system (1) comprising:
a first injectable material transfer device (2) having a first nozzle (23); and
a second injectable material transfer device (5) having a first nozzle port (the port within 54, leading to 56, as viewed in Figure 6) configured to be seated with respect to (as shown in Figure 6) said first nozzle (23) of said first injectable material transfer device (2), and a first nozzle pocket (the pocket within 54 within which 23 sits, as viewed in Figure 6) configured to guide (as shown in Figure 6) said first nozzle (23) of said first injectable material transfer device (2) as said first injectable material transfer device (2) and said second injectable material transfer device (5) are brought together (as shown in Figure 6) generally axially (up and down, as viewed in Figure 6) and are rotated with respect to each other (via the threads on 54/52) to seat (as shown in Figure 6) said first nozzle (23) of said first injectable material transfer device (2) with respect to (as shown in Figure 6) said first nozzle port (the port within 54, leading to 56, as viewed in Figure 6) of said second injectable material transfer (5).
As to Claim 9, Greter teaches all the limitations of Claim 1, and continues to teach said first injectable material transfer device (2) is a multi-chamber device (as shown in Figure 1) defining a first chamber (21) and a second chamber (22) therein;
said first injectable material transfer device (2) has a second nozzle (23);
said first nozzle (23) of said first injectable material transfer device (2) is in fluid communication with (as shown in Figure 6) the first chamber (21) of said first injectable material transfer device (2); and
said second nozzle (23) of said first injectable material transfer device (2) is in fluid communication (as shown in Figure 6) with the second chamber (22) of said first injectable material transfer device (2).
As to Claim 10, Greter teaches all the limitations of Claims 1 & 9, and continues to teach said first nozzle port (the port within 54, leading to 56, as viewed in Figure 6) of said second injectable material transfer device (5) is configured to be seated with respect to (as shown in Figure 6) said first nozzle (23) of said first injectable material transfer device (2);
said second injectable material transfer device (5) has a second nozzle port (the port within 54, leading to 56, as viewed in Figure 6) configured to be seated with respect to (as shown in Figure 6) said second nozzle (23) of said first injectable material transfer device (2); and
said second injectable material transfer device (5) has a second nozzle pocket (the pocket within 54 within which 23 sits, as viewed in Figure 6) configured to guide (as shown in Figure 6) said second nozzle (23) of said first injectable material transfer device (2) to seat with respect to (as shown in Figure 6) said second nozzle port (the port within 54, leading to 56, as viewed in Figure 6) of said second injectable material transfer device (5) as said first injectable material transfer device (2) and said second injectable material transfer device (5) are brought together generally axially (2) and are rotated with respect to each other (via the threads on 54/52) to seat said second nozzle (23) of said first injectable material transfer device (2) with respect to (2) said second nozzle port (the port within 54, leading to 56, as viewed in Figure 6) of said second injectable material transfer (5).
As to Claim 11, Greter teaches all the limitations of Claims 1 & 9-10, and continues to teach said second injectable material transfer device (5) comprises an injection system comprising a material delivery device (5) configured to deliver injectable material ejected from (the substance described in Paragraph 0056) said first injectable material transfer device (2) and through (via 55) said second injectable material transfer device (5) to a patient (via 315).
As to Claim 12, Greter teaches all the limitations of Claims 1 & 9, and continues to teach said second injectable material transfer device (5) comprises an injection system comprising a material delivery device (5) configured to deliver injectable material ejected from (the substance described in Paragraph 0056) said first injectable material transfer device (2) and through (via 55) said second injectable material transfer device (5) to a patient (via 315).
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.
Claims 1-5, 8 & 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Aramata (U.S. PGPub 2004/0039365), in view of Kuracina (U.S. Patent 11,612,692).
As to Claim 1, Aramata teaches an injectable material delivery system (Figure 8) configured to establish fluid communication between (via 711/723a) first (710) and second (70) injectable material transfer devices thereof, said system comprising (Figure 8):
a first injectable material transfer device (710) having a first nozzle (711); and
a second injectable material transfer device (70) having a first nozzle port (see Aramata Figure 17 below) configured to be seated with respect to (as shown in Figure 17, where first nozzle 711 is shown as 11) said first nozzle (711) of said first injectable material transfer device (710), and a first nozzle pocket (see Aramata Figure 17 below) configured to guide (as shown in Figures 8/17) said first nozzle (711) of said first injectable material transfer device (710) as said first injectable material transfer device (710) and said second injectable material transfer device (70) are brought together (as shown in Figures 8/17) generally axially (up and down, as viewed in Figures 8/17)…to seat (as shown in Figure 8) said first nozzle (711) of said first injectable material transfer device (710) with respect to said first nozzle port (see Aramata Figure 17 below)) of said second injectable material transfer (70).
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Aramata Figure 17, Modified by Examiner
Aramata is silent on how second injectable material transfer device (70) engages with the first injectable material transfer device, so does not explicitly teach the respective devices are rotated with respect to each other.
Kuracina describes a similar delivery system, and teaches the second injectable material transfer device (102c/110; see Figure 5B) having engaging elements (the threads/luers on 102c described in Column 21, Lines 48-52)…to engage (Column 21, Lines 48-52) engaging elements (the threads/luers on 13 described in Column 21, Lines 48-52) of said first injectable material transfer device (13) requiring rotation (due to the threads/luers).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use matching threads, as taught by Kuracina, on the third injectable material device, as taught by Aramata, to provide a tight fit between the respective structures. Additionally, the use of threads to connect respective structures is well-known and yields predictable results, i.e., reliable and easy to use connections.
As to Claim 2, Aramata, as modified, teaches all the limitations of Claim 1, and continues to teach said first injectable material transfer device (Aramata 710) and said second injectable material transfer device (Aramata 70) have engaging elements (the Aramata female grooves on Aramata 723b shown in Aramata Figure 8 and the Aramata male threads/protrusions on Aramata 711 shown in Aramata Figure 8, as taught by Kuracina) configured to couple (Aramata Paragraph 0068) said first injectable material transfer device (Aramata 710) and said second injectable material transfer device (Aramata 70) by relative axial (up and down, as viewed in Aramata Figures 8/17) and/or rotational movements (via the Aramata male and Aramata female screws described in Aramata Paragraph 0068, and shown in Aramata Figure 8, as taught by Kuracina) of said first injectable material transfer device (Aramata 710) and said second injectable material transfer device (Aramata 70), with the guidance (as shown in Aramata Figures 8/17) of said first nozzle pocket (see Aramata Figure 17 in the Claim 1 rejection above).
As to Claim 3, Aramata, as modified, teaches all the limitations of Claims 1-2, and continues to teach a biasing element (Aramata 730) positioned between (as shown in Aramata Figure 8) said first injectable material transfer device (Aramata 710) and said second injectable material transfer device (Aramata 70) to bias (one of ordinary skill in the art would conclude an O-ring would inherently provide a biasing effect due to the elastomeric nature of an O-ring) said first injectable material transfer device (Aramata 710) and said second injectable material transfer device (Aramata 70) with respect to each other (as shown in Aramata Figure 8; Aramata Paragraph 0068) to lock (one of ordinary skill in the art would conclude the pressure applied by Aramata seal 730 would broadly “lock” the described threads with each other) said engaging elements (the Aramata female grooves on Aramata 723b shown in Aramata Figure 8 and the Aramata male threads/protrusions on Aramata 711 shown in Aramata Figure 8, as taught by Kuracina) of said first injectable material transfer device (Aramata 710) and said second injectable material transfer device (Aramata 70) with respect to each other (as shown in Aramata Figure 8; Aramata Paragraph 0068).
As to Claim 4, Aramata, as modified, teaches all the limitations of Claims 1-2, and continues to teach a third injectable material transfer device (Aramata 720) having engaging elements (the female screws described in Aramata Paragraph 0068) configured to be similar to (as taught by Kuracina Column 21, Lines 48-52) engaging elements (the female screws described in Paragraph 0068) of said second injectable material transfer device (Aramata 70) to engage (Aramata Paragraph 0068) engaging elements (the male screws described in Aramata Paragraph 0068) of said first injectable material transfer device (Aramata 710).
As to Claim 5, Aramata, as modified, teaches all the limitations of Claims 1-2 & 4, and continues to teach said third injectable material transfer device (Aramata 720) has a first nozzle port (the port above Aramata 730, as viewed in Aramata Figure 8) configured to be seated with respect to (as shown in Aramata Figure 18) said first nozzle (Aramata 711) of said first injectable material transfer device (Aramata 710), and a first nozzle pocket (the pocket with Aramata 723b, as viewed in Aramata Figure 8) configured to guide (as shown in Aramata Figure 8) said first nozzle (Aramata 711) of said first injectable material transfer device (Aramata 710) as said first injectable material transfer device (Aramata 710) and said third injectable material transfer device (Aramata 720) are brought together (as shown in Aramata Figure 18) generally axially (up and down, as viewed in Aramata Figure 8) and are rotated (due to the Aramata female grooves on Aramata 723b shown in Aramata Figure 8 and the Aramata male threads/protrusions on Aramata 711 shown in Aramata Figure 8) with respect to each other to seat (as shown in Aramata Figure 8) said first nozzle (Aramata 711) of said first injectable material transfer device (Aramata 70) with respect to said first nozzle port (the port above Aramata 730, as viewed in Aramata Figure 8) of said third injectable material transfer device (Aramata 720).
As to Claim 8, Aramata teaches all the limitations of Claim 1, and continues to teach said first injectable material transfer device (Aramata 710) is selected from the group consisting of: a device (Aramata Figure 8) defining a material chamber therein (below Aramata 713, as shown in Aramata Figure 8) and having at least one nozzle (Aramata 711) through which material (Aramata MD) is ejected therefrom (as shown in Aramata Figure 8) or aspirated therein; a multi- chamber device; a single-chamber device; a device defining a nozzle port with respect to which a nozzle of another device may be seated in fluid communication therewith; a vial adaptor; an injection system; a pretreatment system; or an adaptor device or system coupling or facilitating coupling of a first device with at least one nozzle with a second device with at least one nozzle port. Since the first option is taught by Aramata, the remaining options do not need to be taught.
As to Claim 13, Aramata teaches all the limitations of Claim 1, and continues to teach said first injectable material transfer device (Aramata 710) has a barrel defining a first chamber therein (below Aramata 713, as shown in Aramata Figure 8), and a plunger assembly (see Aramata Figure 16 below) movable with respect to (as shown in Aramata Figure 16) the first chamber (below Aramata 713, as shown in Aramata Figure 8, which is shown as V in Aramata Figure 16) to eject (as shown in Aramata Figure 16) material (Aramata MD) from (as shown in Aramata Figure 16) or to aspirate material into the first chamber (below Aramata 713, as shown in Aramata Figure 8, which is shown as V in Aramata Figure 16). Aramata Paragraph 0075 describes the Aramata solution container 710 as a syringe, similar to the syringe shown in Aramata Figure 16.
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Aramata Figure 16, Modified by Examiner
As to Claim 14, Aramata teaches all the limitations of Claims 1 & 13, and continues to teach said second injectable material transfer device (Aramata 70) comprises an injection system comprising a material delivery device (Aramata 70) configured to deliver (via the needle portion of Aramata 70) injectable material (Aramata MD) ejected from (Aramata Paragraph 0077) said first nozzle (Aramata 711, shown as 11 in Aramata Figure 16) of said first injectable material transfer device (Aramata 710, shown as P in Aramata Figure 16) and through said injection system (Aramata 70) to a patient (Aramata Paragraph 0077).
As to Claim 15, Aramata teaches all the limitations of Claims 1 & 13-14, and continues to teach a vial adaptor (Aramata 720) having:
a vial-receiving chamber (the chamber within Aramata 721, as viewed in Aramata Figure 8, within 21, as viewed in Aramata Figure 16) configured to receive a vial therein (as shown in Aramata Figure 16);
a first nozzle port (the port just above Aramata seal 730, as viewed in Aramata Figure 8) configured to be seated with respect to (as shown in Aramata Figure 8) said first nozzle (Aramata 711) of said first injectable material transfer device (Aramata 710); and
a first nozzle pocket (the pocket within Aramata 723a, as viewed in Aramata Figure 8) configured to guide (as shown in Aramata Figure 8) said first nozzle (Aramata 711) of said first injectable material transfer device (Aramata 710) as said first injectable material transfer device (Aramata 710) and said vial adaptor (Aramata 720) are brought together (as shown in Aramata Figure 8) generally axially (up and down, as viewed in Aramata Figure 8) and are rotated (via the male and female screws described in Aramata Paragraph 0068, and shown in Aramata Figure 8) with respect to each other (Aramata Paragraph 0068) to seat (as shown in Aramata Figure 8) said first nozzle (Aramata 711) of said first injectable material transfer device (Aramata 710) with respect to said first nozzle port (the port just above Aramata seal 730, as viewed in Aramata Figure 8) of said vial adaptor (Aramata 720).
Allowable Subject Matter
Claims 6-7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As to Claims 6/7, the prior art of record teaches each of the limitations of Claims 1-2 & 4-5 but does not teach “a fourth injectable material transfer device having engaging elements configured to be similar to engaging elements of said first injectable material transfer device to engage engaging elements of said second injectable material transfer device”. Therefore, the prior art of record fails to disclose each of the limitations of Claims 6/7. The closest art of record is Aramata, in view of Kuracina (cited above). However, neither Aramata nor Kuracina describe a fourth injectable material transfer device with the claimed features. It would not be obvious to one of ordinary skill in the art to modify Aramata, in view of Kuracina without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claims 6/7, is neither anticipated nor made obvious by the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bublewitz (2013/0265846 – see Figure 14) describes a similar delivery system.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
