DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The claims use the phrase “formed over a periphery of the slit” to describe the seal part/rib structure, whereas the specification instead uses the phrase “formed along the periphery of the slit” to describe the rib structure (see [0026], [0052], and [0075]). The terms “over” and “along” are therefore, in this context and in the context of the specification, interpreted as interchangeable.
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 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: “seal part” in claims 8-10.
Specifically, the limitation “seal part” in claim 8 invokes 35 U.S.C. 112(f) since,
the term “part” is a non-structural generic placeholder, having no specific structural meaning, which would not be recognized by one of ordinary skill in the art as being sufficiently definite structure for performing the claimed function,
this term is modified by the functional language “seal” and “configured to … match and seal the tip of the connecting member”, which expresses the intended use of the “part”, thereby setting forth the “part” in terms of the function it performs rather than the specific structure, material, or acts that perform the function, and
this term is not modified by sufficient structure, material, or acts for achieving the specified function within the claims.
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.
Specifically, the limitation “seal part” in claims 8-10 is interpreted to include the disclosed rib structure, which is described in the specification as performing the claimed function (see specification, [0093-0094]), and equivalents thereof.
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.
Claims 8-10 and 12 are 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. Claim 8 recites the limitation “a seal part formed over a periphery of the slit … and configured to… match and seal the tip of the connecting member” without tying this seal part feature to any particular structure. The specification, however, only describes a single species for this function: the rib 9b (see [0026], [0052], and [0075]). Claim 11 subsequently narrows “seal part” to the single species of “comprised of a rib”, thereby suggesting that the applicant understood claim 8 to be broader than the disclosed rib structure. Thus, because the applicant has failed to provide a sufficient number of representative species falling within the claimed genus or provide common structural features that would allow one of ordinary skill in the art to recognize that the inventor possessed the entre claimed genus, it is evident that the genus limitation “a seal part formed over a periphery of the slit … and configured to… match and seal the tip of the connecting member” 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. See MPEP 2163(II)(3)(ii), 2163.03(V), and 2163.05(B).
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.
Claims 2, 4, and 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 2 and 4, each claim recites the limitation “further comprising a seal part formed over the periphery of the slit in the valve”, however, both claims depend from claim 1, which defines “a rib integrally formed over a periphery of the slit in the valve.” Because the specification provides no alternative embodiment of a seal part other than that of “a rib integrally formed over a periphery of the slit in the valve”, these limitations within claims 2 and 4 are rendered indefinite. Specifically, it is unclear whether they refer to a second, distinct component (which is unsupported by the specification), or whether they refer to the rib of claim 1. Appropriate clarification or correction is required. For examination purposes, the latter interpretation is presented as the most reasonable interpretation in light of the specification.
Regarding claims 15 and 17, each claim recites the limitation “a large thickness.” The term “large” in these claims is a relative term which renders the claim indefinite. The term “large” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. No baseline for comparison is given within the claims or specification by which the term “large” may be interpreted. It is thus unclear whether the outer peripheral edge must be large with respect to the inner peripheral depression, the locking part, or some absolute value, for example. This uncertainty in scope renders the claim indefinite. Appropriate clarification or correction are required. For examination purposes, the term is interpreted under broadest reasonable interpretation as being relative to any of the exemplary baselines of comparison.
Regarding claims 16 and 17, while being introduced as method claims, each claim consists entirely of description of a product (the cap part of the access port of claim 13) and are devoid of any method steps. This renders the claim indefinite, since it is unclear what acts would constitute infringement upon a method claim that solely contains descriptive language concerning an apparatus. Appropriate correction (such as, for example, restating the descriptive manufacturing language of claim 16 into active method steps) is required.
Regarding claims 18, 19, and 20, each claim makes reference to “the body” according to a previous claim (claims 1, 8, and 13 respectively) as being connected to a claimed flow route. However, these previous claims define a body, valve, cap, and in some cases a rib/seal part as separate but related elements together forming an access port member. It is thus unclear whether referencing “the body” according to the respective previous claim imports the entire combination (valve/cap/rib and their relationships to the body) or only the “a body having an opening” limitation of the previous claim. Appropriate clarification or correction is required. For examination purposes, the latter interpretation is presented (it being the broader reasonable interpretation).
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) 1-2, 5, 7-8, 11-12, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fukai (JP2008301885A).
Regarding claim 1, Fukai discloses an access port member (injection tube/pipe 1) comprising: a body (pipe body 10) having an opening (branch hole 13 - see Fig. 1 and [0016]); a valve (seal valve 30) made of an elastic member (silicone rubber or natural rubber) covering the opening and attached to an attachment part of the body (see Fig. 1-3, [0019], and [0021], wherein the seal valve 30 is attached via its base 31, which is received within an attachment part in the form of an annular cavity formed between support portion 16 and protruding portion 17 of the body and fixed thereto by the attachment of cap member 20 to the body), the valve including a slit (slit 34) that makes a transition from a closed state (Fig. 2) to an open state (Fig. 3) when pressed by a tip (syringe mouth 44) of a connecting member (syringe 40/41) capable of collecting blood or injecting a drug (see Fig. 2-3, [0001], [0019], and [0024-0026]); a cap part (cap member 20, comprised of sleeve portion 21 and flange portion 22) fixed to the body with the valve interposed therebetween and the slit facing outward (see Fig. 1-3, [0017], and [0021]), the cap part having a locking part (male screw/thread 23 provided on sleeve portion 21) with a thread shape to be screwed and locked into a thread shape (female screw/thread 46) formed in the connecting member (on collar 45 of the syringe – see Fig. 3-4, [0017], [0023], and [0025]); and a rib (annular projection 36) integrally formed over a periphery of the slit in the valve (formed on the outer diameter end of the upper surface of the valve portion 33, peripheral to the slit – see Fig. 1-3 and [0020]).
Regarding claim 2, Fukai further discloses a seal part (annular projection 36) formed over the periphery of the slit in the valve (see in re claim 1) and configured to, when the slit is in an open state, match and seal the tip of the connecting member (see Fig. 3, [0020], [0026], and [0028], wherein annular projection 36 is pressed against the tip of the mouth/tip portion 44 of the syringe when the syringe is pushed into the branch passage 3 formed within the hollow sleeve portion 21 of the cap member 20, deforming cooperatively with upright portion 32 of the valve to conform to the shape of the mouth/tip portion of the syringe, thereby forming a tight seal between the mouth/tip portion and the valve).
Regarding claim 5, Fukai further discloses that the rib is composed of a protrusion (annular projection 36) formed on a front surface of the valve (see Fig. 1-2 and [0020]), is circular in a plan view (see Fig. 1a and [0019-0020], wherein the annular projection 36 is annular – i.e. circular – consistent with the overall circular construction of the valve), and has an internal region (portion of the upper surface of valve portion 33 which is bounded by the annular projection 36) in which the slit is formed (see 1-3 and [0019-0020]).
Regarding claim 7, Fukai further discloses that the slit is formed in a line segment shape (see Fig. 1a and 2).
Regarding claim 8, Fukai discloses an access port member comprising: a body having an opening (see in re claim 1); a valve made of an elastic member covering the opening and attached to an attachment part of the body, the valve including a slit that makes a transition from a closed state to an open state when pressed by a tip of a connecting member capable of collecting blood or injecting a drug (see in re claim 1); a cap part fixed to the body with the valve interposed therebetween and the slit facing outward, the cap part having a locking part with a thread shape to be screwed and locked into a thread shape formed in the connecting member (see in re claim 1); and a seal part formed over a periphery of the slit in the valve and configured to, when the slit is in an open state, match and seal the tip of the connecting member (see in re claim 2).
Regarding claim 11, Fukai further discloses that the seal part is comprised of a rib (annular projection 36) which is formed by copying a shape of the tip of the connecting member (see Fig. 2-4 and [0020], wherein the annular projection copies/corresponds in shape to the annular lip of the syringe mouth/tip 44 such that it is positioned and dimensioned to contact the annular lip of the syringe mouth/tip upon insertion of the syringe mouth/tip into the branch passage 3).
Regarding claim 12, Fukai further discloses that the slit is formed in a line segment shape or a cross shape (see in re claim 7).
Regarding claim 18, Fukai further discloses a flow route comprising: a blood circuit configured to cause a patient's blood to extracorporeally circulate; a liquid delivery circuit configured to inject a liquid drug or blood to a patient; and/or a liquid drug delivery circuit configured to cause a liquid drug to flow, the flow route being connected to the body according to Claim 1 (see Fig. 1a-1c, [0001], [0016], and [0027], wherein the device of Fukai is intended for extracting and injecting fluids such as blood or drug solutions during intravenous drip or hemodialysis, and wherein connecting portions 12a, 12b at both ends of pipe body 10 may be connected to infusion piping, and see in re claim 1).
Regarding claim 19, Fukai further discloses a flow route comprising: a blood circuit configured to cause a patient's blood to extracorporeally circulate; a liquid delivery circuit configured to inject a liquid drug or blood to a patient; or a liquid drug delivery circuit configured to cause a liquid drug to flow, the flow route being connected to the body according to Claim 8 (see Fig. 1a-1c, [0001], [0016], and [0027], wherein the device of Fukai is intended for extracting and injecting fluids such as blood or drug solutions during intravenous drip or hemodialysis, and wherein connecting portions 12a, 12b at both ends of pipe body 10 may be connected to infusion piping, and see in re claim 8).
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) 3-4, 9, 13-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fukai in view of Christensen (U.S. Pat. Pub. No. 2015/0119863 A1).
Regarding claim 3, Fukai discloses the access port member according to claim 1. Fukai fails to teach that the thread shape of the locking part is formed such that a thread height at a terminal end is higher than a thread height in other portions. However, such a threading configuration is well known within many fields of art. Christensen, for example, exhibits an external threading (threads 140) configuration for a locking part (cylindrical hollow sleeve) of a cap member (body 120) of a medical connector/access port (Luer access device 100) similar to that of Fukai (see Fig. 1-3 and 9, [0028-0030], and [0050-0051]). Christensen teaches, in the embodiment of Fig. 9, that the thread shape of the locking part may be formed such that a thread height at a terminal end (end at which the cylindrical hollow sleeve joins the remainder of the body 120 and at which retention feature 650 is provided) is higher than a thread height in other portions (the remainder of the threads 140 extending between the retention feature 650 and the tip of the cylindrical hollow sleeve) in order to thereby increase the frictional forces between the external threading of the connector/access port and a device threadedly attached thereto once the device threading has fully advanced to the terminal end, thereby providing a more secure connection and providing the user with tactile feedback indicating that a secure and complete connection has been established ([0001], [0009-0010], [0040-0041], and [0050-0051]). Based on the teachings and example of Christensen, it would thus have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the thread shape of the locking part of Fukai to include a retention feature such as that taught in the embodiment of Fig. 9 of Christensen, such that a thread height at a terminal end is higher than a thread height in other portions, in order to thereby increase the frictional forces between the external threading of the connector/access port and a device threadedly attached thereto once the device threading has fully advanced to the terminal end, thereby providing a more secure connection and providing the user with tactile feedback indicating that a secure and complete connection has been established, as described by Christensen ([0001], [0009-0010], [0040-0041], and [0050-0051]).
Regarding claim 4, Fukai further discloses a seal part (annular projection 36) formed over the periphery of the slit in the valve and configured to, when the slit is in an open state, match and seal the tip of the connecting member (see in re claim 2). Fukai may be modified according to the teachings of Christensen, as described above in re claim 3, such that Fukai as modified by Christensen exhibits that the thread shape of the locking part is formed such that a thread height at a terminal end is higher than a thread height in other portions (see in re claim 3).
Regarding claim 9, Fukai may be modified according to the teachings of Christensen, as described above in re claim 3, such that Fukai as modified by Christensen exhibits that the thread shape of the locking part is formed such that a thread height at a terminal end is higher than a thread height in other portions (see in re claim 3).
Regarding claim 13, Fukai discloses an access port member comprising: a body having an opening (see in re claim 1); a valve made of an elastic member covering the opening and attached to an attachment part of the body, the valve including a slit that makes a transition from a closed state to an open state when pressed by a tip of a connecting member capable of collecting blood or injecting a drug (see in re claim 1); and a cap part fixed to the body with the valve interposed therebetween and the slit facing outward, the cap part having a locking part with a thread shape to be screwed and locked into a thread shape formed in the connecting member (see in re claim 1). While Fukai does not teach that the thread shape of the locking part is formed such that a thread height at a terminal end is higher than a thread height in other portions, Fukai may be modified according to the teachings of Christensen, as described above in re claim 3, such that Fukai as modified by Christensen exhibits that the thread shape of the locking part is formed such that a thread height at a terminal end is higher than a thread height in other portions (see in re claim 3).
Regarding claim 14, Christensen further teaches that the thread shape of a locking part of an access port like that of Fukai may include a first thread region (region extending from the flat, maximum thickness portion of the retention feature 650 to the top surface of the wider body 120) that constitutes the terminal end, and a second thread region (forward ramped surface 652) where a thread height gradually increases toward the terminal end (see Fig. 9 and [0050-0051]). Based on this example, and the teachings of Christensen described above (see in re claim 3), it would further have been obvious to one of ordinary skill in the art to incorporate, as part of the above modification in re claim 13, a first thread region that constitutes the terminal end, and a second thread region where a thread height gradually increases toward the terminal end, as taught by Christensen, for the same reasons as discussed above in re claim 3.
Regarding claim 15, Fukai further discloses that in the cap part, an inner peripheral depression is formed around the locking part (see Fig. 1a-3, wherein an inner peripheral depression – i.e. an annular gap – is formed separating the sleeve portion 21 from a portion of the cap member 20 which climbs over and engulfs the cylindrical portion 14 of the pipe body 10 within annular recess 24), and an outer peripheral edge (the portion of the cap member 20 which climbs over and engulfs the cylindrical portion 14 of the pipe body 10, forming annular recess 24) located on an outer diameter side of the inner peripheral depression is formed to have a large thickness (see Fig. 1b-1c, wherein it is visually apparent that the thickness of this portion of the cap member is greater than the thickness of the cap member at the bottom of the inner peripheral depression portion, thereby it is large in comparison to this feature).
Regarding claim 20, within the combination of Fukai as modified by Christensen, Fukai further discloses a flow route comprising: a blood circuit configured to cause a patient's blood to extracorporeally circulate; a liquid delivery circuit configured to inject a liquid drug or blood to a patient; and/or a liquid drug delivery circuit configured to cause a liquid drug to flow, the flow route being connected to the body according to Claim 13 (see Fig. 1a-1c, [0001], [0016], and [0027], wherein the device of Fukai is intended for extracting and injecting fluids such as blood or drug solutions during intravenous drip or hemodialysis, and wherein connecting portions 12a, 12b at both ends of pipe body 10 may be connected to infusion piping, and see in re claim 13).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fukai in view of Ueda (WIPO Pub. No. 2013/146740A1).
Regarding claim 10, Fukai further discloses that the seal part is in contact (at least partial contact) with the tip of the connecting member during a closed state and an open state (this being clear from Fig. 2 and 3 and [0020], [0026], and [0028] of Fukai). While Fukai does not explicitly disclose that the seal part maintains a contact state with the tip of the connecting member during a transition of the slit from a closed state to an open state and during a transition of the slit from an open state to a closed state, such a configuration is known in the art for valves of the type disclosed by Fukai. For example, Ueda exhibits an access port/medical connector (connector 1) similar to that of Fukai, capable of receiving a connecting member (male connector) of the same type and comprising an elastic valve (valve body 3) with a slit (slit 33) formed therein in a similar manner to that of Fukai (see Fig. 1-3 and 9A-10F, English Translation, pg. 3, ln 17 – pg. 4, ln 14). Ueda explicitly teaches that the seal may be configured to maintain continuous contact between the valve’s front surface (connector-facing top-surface comprising annular protrusion 31a, wall surface 35b of the annular protrusion 31a, and bottom surface 35a) and the connector tip throughout both the insertion and withdrawal of the connecting member (opening and closing of the valve) in order to thereby prevent the valve’s elastic material from catching on itself and thereby failing to fully return to its closed, sealed shape (see Fig. 9A-10D and English Translation, pg. 28, ln 17 - pg. 29, ln 3). It should also be notes that, as part of the shaping of the valve’s front surface, an annular rib/protrusion (31a) of the type taught by Fukai is provided peripheral to and enclosing the interior portion (bottom surface 35a) of the valve front surface comprising the slit (see Fig. 1-8, English Translation, pg. 15, ln 13 – pg. 16, ln 11, and English Translation, pg. 24-29). Based on the teachings and example of Ueda, it would have been obvious to and well within the skill set of one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve of Fukai by configuring/shaping the seal part (annular projection 36) and the remainder of the valve in order to maintain a contact state between the seal part and the tip of the connecting member during a transition of the slit from a closed state to an open state and during a transition of the slit from an open state to a closed state according to the design concept taught by Ueda, in order to thereby prevent the valve’s elastic material from catching on itself and thereby failing to fully return to its closed, sealed shape (as is required in order to maintain sterility within the access port and downstream components/patients, and to prevent leakage), as described in Ueda (English Translation, pg. 28, ln 17 - pg. 29, ln 3).
Claim(s) 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Fukai as modified by Christensen according to claim 13 and in further view of Auerbach (U.S. Pat. Pub. No. 2020/0101238 A1).
Regarding claim 16, Fukai discloses a method of manufacturing the access port member according to Claim 13, wherein the cap part is comprised of a component obtained by resin molding ([0017]). Fukai fails to teach that the cap may be produced using a rotating mold having a profile on an inner peripheral surface and removable by rotation along a spiral of the thread shape, the profile corresponding to the thread shape of the locking part, however, such techniques are well known in the art of injection molded fluid transfer devices. Auerbach, for example, exhibits an injection molded connecting member (syringe 1) configured to connect with a medical connector of the type taught by Fukai, and thereby comprising a locking part (Luer collar 11) with threads (inner thread 12) in a similar manner to the access port member of Fukai (see Fig. 1-4 and [0041-0047]). Auerbach teaches that a threaded feature which must extend internally to a collar/depression structure all the way to a bottom surface of the collar/depression structure may not be accommodated by a straight-pull mold, and may instead be produced using a rotating mold (screw core), which is rotated/unscrewed for demolding after the injection molding procedure ([0037]). Since Fukai does not provide any teaching concerning how the cap part is injection molded, one of ordinary skill in the art would be required to look to such known methods. Further, since the threads of the locking part of Fukai extend internally to a collar/depression structure (threads 23 extending at their terminal end within the inner peripheral depression formed separating the sleeve portion 21 from a portion of the cap member 20 which climbs over and engulfs the cylindrical portion 14 of the pipe body 10 within annular recess 24) all the way to a bottom surface of the collar/depression structure (see Fig. 1b-3) in a similar manner to those of Auerbach, and are externally provided to the locking member (sleeve portion 21), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the cap member using a mold which is at least in part (the relevant part forming the locking member and surrounding structures) a rotating mold having a profile on an inner peripheral surface (as would be necessary to produce an external thread) and removable by rotation along a spiral of the thread shape (as in the manner taught by Auerbach), the profile corresponding to the thread shape of the locking part (this principle of inversely corresponding profiles being well understood within the art of molding), in order to thereby accommodate the extension of the threads of the locking member internally to the collar/depression structure of Fukai in a manner which could not be accommodated using other molding techniques, such as a straight-pull mold.
Regarding claim 17, Fukai further discloses that in the cap part, an inner peripheral depression is formed around the locking part, an outer peripheral edge located on an outer diameter side of the inner peripheral depression is formed to have a large thickness (see in re claim 15). In order to achieve such shaping, the rotating mold of the above combination would be required to have a profile corresponding to the inner peripheral depression on an outer peripheral end of at least a portion thereof (this principle of inversely corresponding profiles being well understood within the art of molding). It thus would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention, as part of the above modification in re claim 16, to configure the rotational molding of the cap part of Fikai such that the rotating mold has a profile corresponding to the inner peripheral depression on an outer peripheral end.
Allowable Subject Matter
Claim(s) 6 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art cited in this office action and any prior office actions represents the closest art to the claimed invention as found by the examiner. Regarding the above cited claims, none of these references teach or suggest the claimed invention as a whole, and it would not have been obvious to one of ordinary skill in the art at the time of filing to combine teachings from these references to obtain the claimed invention. In support of this finding, a comparison of the present claim limitations to the closest prior art is presented below.
Regarding claim 6, the claim recites the limitation “part of the slit extends to a tip surface of the rib”, which alongside the remainder of the claim and any intervening claims renders the claim patentably distinct over the prior art. It should first be noted that the phrase “internal region” within the limitation “wherein the rib … has an internal region in which the slit is formed” of claim 5 and the similar limitation in claim 6 is interpreted, in light of the limitation “a rib … formed over a periphery of the slit in the valve” of claim 1 and in view of the specification as meaning a region at least partially encompassed by (interior to) the perimeter defined by the rib, rather than a region internal to (cut into) the rib structure itself. This interpretation precludes some needleless connector configurations wherein a rib is formed directly onto/over the slit, such as in U.S. Pat. No. 6,344,033 and WIPO Pub. No. 01/20218.
While Fukai teaches the subject matter of claims 1 and 5, upon which claim 6 depends, and further teaches that the slit is formed in the internal region surrounded by the annular rib (see in re claim 5), neither Fukai nor any other reference discovered by the Office exhibits or suggests that the slit may extend to alignment or contact with a tip surface of such a rib. Included in this assessment is all prior art cited by the applicant(s) and provided by the applicant(s) within the IDS forms provided. The closest reference found to the claimed configuration was WIPO Pub. No. WO02064077A1, wherein a valve of the type claimed in provided which comprises a raised, annular rim/rib (raised annular portion of plug body 1 extending between protruding portion 1b and recess 1e) peripheral to and raise above an internal/interior portion of the valve (concave portion 1c) comprising a slit (linear cut portion 1a), wherein it is visually apparent from Fig. 2 of the reference that the slit may extend up to contact/alignment with the base of the rim/rib. No depiction or suggestion is made, however, that the slit could extend into contact or alignment with the tip surface of such a raised, annular rim/rib. Since these references represent the closest prior art to the claimed configuration, and since no other reference was found by the examiner which discloses or teaches this limitation(s), it is thus concluded that this limitation(s), in combination with the remainder of the claim and any intervening claims, is/are patentably distinct over prior art. Any claims that are dependent upon this claim are also considered to be patentably distinct over prior art by virtue at least of the subject matter of this claim.
Conclusion
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
