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
This office action is responsive to the amendment filed on June 9, 2025. As directed by the amendment: claims 1, 19, 27, 32, 38, 41, 77, 85, 101, 137 have been amended, claims 141-143 have been added, claims 31, 46, 49, 62 have been canceled. Thus claims 1, 3, 10-11, 19, 27, 32, 38, 41, 77, 84-85, 101, 117, 127, 137 and 141-143 are presently pending in this application. Applicant’s amendments to the Claims/Specification have overcome each and every objection and 35 U.S.C. 112(b) rejection previously set forth in the Non-Final Office Action mailed January 10, 2025.
Response to Arguments
Applicant’s arguments, see Remarks, filed June 9, 2025, with respect to the rejections of claim 1, 3, 10-11, 19, 27, 32, 38, 41, 77, 84-85, 101, 117, 127, 137 under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Schnall fails to disclose the amended limitation of claim 1(limitation previously presented in claims 31-32): a communicating means comprising at least one main chamber located in the carrier element or in the operating means, the at least one main chamber communicating the at least one microneedle with a source of the fluid to be delivered to a subject through the microneedle device for accommodating the fluid from the source to the at least one microneedle. Therefore, the rejections of claims 3, 10-11, 19, 27, 32, 38, 41, 77, 84-85, 101, 117, 127, 137 have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
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.
Claim limitation(s) being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is/are:
“operating means” in claim 1.
“communicating means” in claim 1.
“fluid delivery means” in claim 32
“shielding means” in claim 84.
“operating means” in claim 137.
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. “Operating means” is given the broadest reasonable interpretation of “a solid tubular member of substantially circular external transverse cross-section” (specification, [0144]), “an inflatable member, for example a balloon” (specification, [0196]), or equivalents thereof. “Communicating means” is given the broadest reasonable interpretation of “at least one chamber located in one of the carrier element and the operating means” (specification, [0025]) or equivalents thereof. “Fluid delivery means” is given the broadest reasonable interpretation of “an elongated fluid delivery needle” (specification, [0148]) or equivalents thereof. “Shielding means” is given the broadest reasonable interpretation of “an elongated tubular shield” (specification, [0057]), or 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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 11, 19, 27, 32, 84-85, 101, 127, 141 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orr (US 20110166516).
Regarding claim 1, Orr discloses a microneedle device (Fig. 1, microneedle device 20) comprising: a carrier element defining a longitudinally extending main axis (Fig. 1, catheter 40 and balloon 60 form carrier element), at least one microneedle defining a needle axis (Fig. 1, needles 80), the at least one microneedle being carried on the carrier element with the needle axis extending substantially transversely relative to the main axis defined by the carrier element (Fig. 1, needles 80 carried on carrier element 40/60 with needle axis transverse relative to carrier element axis), an operating means (Fig. 1, operating means 50) co-operable with the carrier element or the at least one microneedle for urging the microneedle transversely outwardly relative to the main axis from a rest state to an engagement state for engaging tissue (Figs. 1-2 and [0040], operating means 50 configured to urge needles outwards to pierce target tissue), and a communicating means (Fig. 1, communicating means 64) comprising at least one main chamber located in the carrier element or in the operating means (Fig. 1-2, communicating means 64 comprises at last one main chamber/pocket 64 which is within the carrier element 40/60), the at least one main chamber communicating the at least one microneedle with a source of the fluid to be delivered to a subject through the microneedle device for accommodating the fluid from the source to the at least one microneedle (Fig. 1-2 and 10 and [0065], main chamber 64 may communicate with a port connected to a source of therapeutic agent, for accommodating the fluid from the source to the needles 80).
Regarding claim 3, Orr discloses a microneedle device as claimed in Claim 1 in which the carrier element defines a main bore extending longitudinally into the carrier element from a proximal end thereof (Fig. 1, carrier element 40/60 has an internal bore extending its length), and the operating means is engageable in the main bore defined by the carrier element and is configured for increasing the cross-section of the main bore defined by the carrier element (Fig. 1-2 and [0039-0041], operating means 50 extends through bore of carrier element and is configured to increase the cross-section of the bore/the device as a whole).
Regarding claim 11, Orr discloses a microneedle device as claimed in Claim 1 in which the operating means comprises an expandable member of expandable transverse cross-section (Fig. 1 and [0031, 0039-0041], operating means is a balloon member with an expandable transverse cross-section).
Regarding claim 19, Orr discloses a microneedle device as claimed in Claim 1 in which the carrier element comprises a pair of shells (Annotated Fig. 1, carrier element 40/60 comprises a pair of shells, the outer shell and inner shell) resiliently urged towards each other into a rest state with the at least one microneedle in the rest state thereof (Annotated Fig. 1 and Fig. 3, outer shell and inner shell are biased towards each other in the rest state due to the outer shell forming recesses 65, to position the needles 80 in the rest state).
Regarding claim 27, Orr discloses a microneedle device as claimed in Claim 19 in which the resilient urging of the shells into the rest state thereof resiliently urges the shells into sealing engagement with the operating means (Annotated Fig. 1 and Fig. 3, shells are urged together and urged into a sealed engagement against the outer surface of operating means 50).
Regarding claim 32, Orr discloses a microneedle device as claimed in Claim 1 in which the main chamber is configured to communicate with a fluid delivery means configured to deliver a fluid from a remote source to the main chamber (Fig. 1-2 and 10 and [0065], main chamber 64 may communicate with deliver channel 42 and a port connected to a remote source of therapeutic agent, for accommodating the fluid from the remote source to the needles 80).
Regarding claim 84, Orr discloses a microneedle device as claimed in Claim 1 further comprising a shielding means for protecting the microneedles ([0039], device may comprise an outer sheath as a shielding means).
Regarding claim 85, Orr discloses a microneedle device as claimed in Claim 84 in which the shielding means comprises a tubular shield having a carrier element accommodating bore extending therethrough for accommodating the carrier element and the microneedles therein when the microneedles are in the rest state thereof; and shielded therein ([0039], device may comprise an outer sheath shielding means which accommodates the apparatus 20 (including carrier element 40/60 and needles 80) within it to shield the needles 80 from the tissue).
Regarding claim 101, Orr discloses a microneedle device as claimed in Claim 1 for use in a method for the treatment of a site in a human or animal body with an injectable fluid (Fig. 1-5, device 20 used for treating a human body site with an injectable fluid agent).
Regarding claim 127, Orr discloses a method for treating a site in a lumen, vessel, cavity, organ or muscular organ comprising inserting a microneedle device as claimed in Claim 1 into the lumen, vessel, cavity, organ or muscular organ (Fig. 1 and 3 and [0038-0039], device 20 is inserted into the body and advanced to target site in a vessel), urging the at least one microneedle of the microneedle device into a wall or tissue of the lumen, vessel, cavity, organ or muscular organ adjacent the site thereof to be treated (Fig. 2 and 4 and [0040], needles 80 pierce into the tissue at/near target site), and delivering a therapeutic fluid through the at least one microneedle into the wall or tissue of the lumen, vessel, cavity, organ or muscular organ (Fig. 2 and 5 and [0040], therapeutic agent is delivered to target site via the needles).
Regarding claim 141, Orr discloses a microneedle device as claimed in Claim 19 in which the shells are urgeable radially outwardly relative to the main axis (Annotated Fig. 1 and Figs. 4-5, inner and outer shells are urgeable radially outward), against the resilient urging of the shells from the rest state to an engagement state by the operating means for urging the at least one microneedle transversely outwardly relative to the main axis from the rest state thereof to the engagement state thereof (Annotated Fig. 1 and Figs. 4-5 and [0040, 0049], inner and outer shells are urged radially outwards by operating means 50 to urge needles 80 outwards into their engagement state).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 10 and 137 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Braga (US 20140276621).
Regarding claim 10, Orr discloses a microneedle device as claimed in Claim 3.
Orr fails to disclose the operating means comprises an operating member, the operating member being of non-deformable transverse cross-section and having a transverse cross-sectional dimension greater than a corresponding transverse cross-sectional dimension of the main bore defined by the carrier element. However, Braga discloses the operating means comprises an operating member (Braga, Figs. 8-9, elongate wire 50), the operating member being of non-deformable transverse cross-section and having a transverse cross-sectional dimension greater than a corresponding transverse cross-sectional dimension of the main bore defined by the carrier element (Figs. 8-9 and [0049], elongate wire has a non-deformable transverse cross-section which has a dimension that is greater than the transverse cross-section of the deformable portions 30 at the treatment length 18 of the catheter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr to incorporate the disclosures of Braga and modify the operating means to have an operating member of non-deformable transverse cross-section such that the operating member has a transverse cross-sectional dimension greater than a corresponding transverse cross-sectional dimension of the main bore defined by the carrier element. Doing so would provide an operating means for the catheter device which allows for smooth engagement between the operating means and the microneedle delivery region, and allows for an operating means which does not require fluid pressure buildup, thus allowing for a quicker delivery of more fluid (Braga, [0049]).
Regarding claim 137, Orr discloses a method for treating a site in a lumen, vessel, cavity, organ or muscular organ of a human or animal subject, the method comprising providing a microneedle device (Fig. 1, microneedle device 20), the microneedle device comprising a carrier element defining a longitudinally extending main axis (Fig. 1, catheter 40 and balloon 60 form carrier element), at least one microneedle defining a needle axis (Fig. 1, needles 80), the at least one microneedle being carried on the carrier element with the needle axis extending substantially transversely relative to the main axis defined by the carrier element (Fig. 1, needles 80 carried on carrier element 40/60 with needle axis transverse relative to carrier element axis), an operating means (Fig. 1, operating means 50) co-operable with the carrier element or the at least one microneedle for urging the microneedle transversely outwardly relative to the main axis from a rest state to an engagement state for engaging tissue (Figs. 1-2 and [0040], operating means 50 configured to urge needles outwards to pierce target tissue), and a communicating means (Fig. 1, communicating means 64) comprising at least one main chamber located in the carrier element or in the operating means (Fig. 1-2, communicating means 64 comprises at last one main chamber/pocket 64 which is within the carrier element 40/60), the at least one main chamber communicating the at least one microneedle with a source of the fluid to be delivered to a subject through the microneedle device for accommodating the fluid from the source to the at least one microneedle (Fig. 1-2 and 10 and [0065], main chamber 64 may communicate with a port connected to a source of therapeutic agent, for accommodating the fluid from the source to the needles 80), providing an elongated tubular shield having a carrier element accommodating bore extending therethrough ([0039], device may comprise an outer sheath shielding means which has a bore that accommodates the apparatus 20 (including carrier element 40/60 and needles 80) within it), inserting the tubular shield with or without the carrier element located in the carrier element accommodating bore thereof from a location exteriorly of the subject through an orifice of the subject to the site in the lumen, vessel, cavity, organ or muscular organ to be treated until the distal end of the tubular shield is located adjacent the site to be treated, and the proximal end of the tubular shield is located exteriorly of the subject (Fig. 2, and [0038-0039], a distal end of an outer sheath may be inserted into a vessel or duct of a subject and advanced to a target site, while proximal end is kept exterior to subject), inserting the carrier element into the tubular shield from the proximal end thereof if the tubular shield is inserted into the subject without a carrier element located in the carrier element accommodating bore thereof , urging the carrier element to the distal end of the tubular shield until the carrier element is located in the carrier element accommodating bore of the tubular shield adjacent the distal end thereof ([0039], outer sheath may be inserted with the drug delivery apparatus 20, Therefore the carrier element 40/60 is inserted and accommodated within a lumen of the outer sheath at the distal end of the outer sheath and is therefore advanced within the lumen of the body until the carrier element 40/60 reaches the target site), partially withdrawing the tubular shield to expose the carrier element and the at least one microneedle adjacent the site to be treated in the lumen, vessel, cavity, organ or muscular organ ([0039], outer sheath may be at least partially retracted to expose the carrier element 40/60 and needles 80 to the target site), and injecting the therapeutic fluid into the wall or tissue of the lumen, vessel, cavity, organ or muscular organ through the at least one microneedle of the carrier element (Fig. 2 and 5 and [0040], therapeutic agent is delivered to target site tissue via the needles 80).
Orr fails to disclose urging an the operating means through the tubular shield until the operating means is adjacent the proximal end of the carrier element while retaining the carrier element in position at the site to be treated, urging the operating means into a main bore defined by the carrier element for in turn urging the at least one microneedle transversely outwardly of athe main axis defined by the carrier element from the rest state to the engagement state into the wall or tissue defining the lumen, vessel, cavity, organ or muscular organ. However, Braga discloses urging an the operating means through the tubular shield until the operating means is adjacent the proximal end of the carrier element while retaining the carrier element in position at the site to be treated (Figs. 8 and [0049], elongate wire 50 may be inserted into the catheter 10 and advanced towards the treatment portion 18 of the catheter, while the treatment portion is positioned ate the target site), urging the operating means into a main bore defined by the carrier element for in turn urging the at least one microneedle transversely outwardly of athe main axis defined by the carrier element from the rest state to the engagement state into the wall or tissue defining the lumen, vessel, cavity, organ or muscular organ (Figs. 8-9 and [0045, 0049], elongate wire 50 may be further urged through the bore of the treatment portion 18 in order to urge deformable portions 30 of treatment portion 18 outwards into the extended position such that the microneedles 36 penetrate the tissue wall).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr to incorporate the disclosures of Braga and modify the method to include urging an the operating means through the tubular shield until the operating means is adjacent the proximal end of the carrier element while retaining the carrier element in position at the site to be treated, urging the operating means into a main bore defined by the carrier element for in turn urging the at least one microneedle transversely outwardly of athe main axis defined by the carrier element from the rest state to the engagement state into the wall or tissue defining the lumen, vessel, cavity, organ or muscular organ. Doing so would provide an operating means for the catheter device which allows for smooth engagement between the operating means and the microneedle delivery region, and allows for an operating means which does not require fluid pressure buildup, thus allowing for a quicker delivery of more fluid (Braga, [0049]).
Claim(s) 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Krulevitch et al. (US 20050273049), hereinafter Krulevitch.
Regarding claim 77, Orr discloses a microneedle device as claimed in Claim 1.
Orr fails to disclose in which each main chamber is located in the operating means, and the operating means is alignable with the carrier element, for aligning the at least one main chamber with a corresponding one or more of the microneedles for communicating the main chamber with the one or more microneedles corresponding to the main chamber. However, Krulevitch discloses in which each main chamber is located in the operating means (Fig. 2, main chamber 235 is located in a portion of the operating means 230), and the operating means is alignable with the carrier element, for aligning the at least one main chamber with a corresponding one or more of the microneedles for communicating the main chamber with the one or more microneedles corresponding to the main chamber (Fig. 1-2 and [0079], operating means 230 is aligned with carrier element 245 which comprises needles 250, such that the main chambers 235 is aligned with and communicate with the corresponding needles 250).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr to incorporate the disclosures of Krulevitch and modify the device such that each main chamber is located in the operating means, and the operating means is alignable with the carrier element, for aligning the at least one main chamber with a corresponding one or more of the microneedles for communicating the main chamber with the one or more microneedles corresponding to the main chamber. Doing so would create a fluid delivery system pierces the tissue and delivers therapeutic fluid based on the operating means/main chamber's interactions, thus ensuring a specific ratio of therapeutic fluid is dispensed during use (Krulevitch, [0077]).
Claim(s) 117 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Tankovich (US 20160287668).
Regarding claim 117, Orr discloses a method for treating a target body site comprising inserting a microneedle device as claimed in Claim 1 into the target (see claim 1 rejection above and Fig. 1 and 3 and [0038-0039], device 20 is inserted into the body and advanced to target site in a vessel), urging the at least one microneedle of the microneedle device into tissue adjacent the target site (Fig. 2 and 4 and [0040], needles 80 pierce into the tissue at/near target site), and delivering a therapeutic fluid through the at least one microneedle into the tissue (Fig. 2 and 5 and [0040], therapeutic agent is delivered to target site via the needles).
Orr fails to disclose that the target site is a fistula. However, Tankovich discloses the target site is a fistula ([0113], microneedle treatment device for treatment of arteriovenous fistula).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr to incorporate the disclosures of Tankovich to modify the device to be used for treatment of a target site which is a fistula. Doing so would allow for use of the device in the treatment of vascular disorders (Tankovich, [0113]).
Claim(s) 142 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Ash (US 20200368493).
Regarding claim 142, Orr discloses a microneedle device as claimed in Claim 32.
Orr fails to disclose the fluid delivery means comprises an elongated fluid delivery needle having a fluid accommodating bore extending therethrough to a distal end thereof. However, Ash discloses the fluid delivery means comprises an elongated fluid delivery needle having a fluid accommodating bore extending therethrough to a distal end thereof (Fig. 1 and [0035], fluid can be delivered to the bores of the device through a needle, which would comprise a fluid accommodating bore extending therethrough to a distal end thereof).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr to incorporate the disclosures of Ash and modify the fluid delivery means to be an elongated fluid delivery needle having a fluid accommodating bore extending therethrough to a distal end thereof. Doing so would provide an advantageous method to provide fluid to the ports/lumens of catheter device (Ash, [0054]).
Regarding claim 38, and Orr, in view of Ash, Orr further discloses a microneedle device as claimed in Claim 142 in which the carrier element or the operating means comprises a fluid delivery needle accommodating duct for accommodating the fluid delivery needle therethrough to the main chamber (Fig. 10, device 20 can have at least one port 272 at the proximal end for receiving the therapeutic agent from the external source/needle).
Claim(s) 41 and 143 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orr (US 20110166516), in view of Ash (US 20200368493), as applied to claim 38 above, and further in view of Asai (US 20110071502).
Regarding claim 41, and Orr, in view of Ash, Orr further discloses a microneedle device as claimed in Claim 38 in which a plurality of the main chambers are provided (Fig. 1, plurality of main chambers 64 are provided), and the fluid delivery needle accommodating duct is configured to communicate with each one of the main chambers (Fig. 1 and 10, port 272 communicates with its respective delivery channel and main chambers 64 (see fig. 1, embodiment only has one delivery channel 42 which communicates with all main chambers 64)).
Orr, in view of Ash, fails to disclose each main chamber is isolated from the fluid delivery needle accommodating duct by a first sealing element, and each first sealing element is configured to sealably accommodate the fluid delivery needle therethrough to the corresponding one of the main chambers. However, Ray discloses each main chamber is isolated from the fluid delivery needle accommodating duct by a first sealing element (Fig. 2 and 4, port 42 is isolated from the downstream components of device via hemostatic valve 44), and each first sealing element is configured to sealably accommodate the fluid delivery needle therethrough to the corresponding one of the main chambers (Fig. 4-5 and [0044], hemostatic valve sealingly accommodates a component to pass therethrough yet still has high liquid tightness).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr, in view of Ash, to incorporate the disclosures of Asai and modify the fluid delivery needle accommodating duct to have a first sealing element, and each first sealing element is configured to sealably accommodate the fluid delivery needle therethrough to the corresponding one of the main chambers. Doing so would maintain the port opening as liquid tight (Asai, [0043-0044]).
Regarding claim 143, Orr, in view of Ash and Asai, discloses a microneedle device as claimed in Claim 41, as explained above. As noted above, Orr and Ash fail to disclose the first sealing element and are thus silent to in which each first sealing element comprises a self-resealing sealing element configured to reseal itself on withdrawal of the fluid delivery needle. However, Asai further discloses in which each first sealing element comprises a self-resealing sealing element configured to reseal itself on withdrawal of the fluid delivery needle (Fig. 4-5 and [0043], hemostatic valve maintains the liquid tight seal when the component is no longer fitted in the port).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr, in view of Ash and Asai, to further incorporate the disclosures of Asai and modify the first sealing element to comprise a self-resealing sealing element configured to reseal itself on withdrawal of the fluid delivery needle. Doing so would maintain the port opening as liquid tight (Asai, [0043-0044]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783