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 Arguments
The previous objection of claims 1 and 18 due to minor informalities has been withdrawn in light of applicant’s amendments made 7/27/2026.
Applicant's arguments filed 7/27/2026 have been fully considered but they are not persuasive. With respect to the Response to Election Requirements filed in this application, applicant argues claims 8 and 9 should be reconsidered because paragraph [0215] states that the Fig. 30 embodiment can include two claw portions like those in the first embodiment. However, [0215] recites “a projection can also be disposed on the securing member 230 including the claw portions 233 and 234 having the structure described in the first embodiment.” Thus, the first embodiment (Species A, Fig. 11-18) with two claws may be modified to include projections, not the third embodiment which was elected. Further, elected Species C in Fig. 30 is identified as a securing member with a first projection on the main body and a second projection on the claw portion i.e. a single claw portion, not two spaced claw portions as identified by Species A. Accordingly, claims 8 and 9 remain withdrawn from prosecution.
With respect to claims 1 and 18, applicant argues the record lacks findings of fact that support the obviousness conclusion of Hioki et al. (WO 2020/111184) in view of Hadian et al. (US 2018/0064868 A1) because the clip of Hadian is used with a portable pump for administering different types of medication or liquid to a patient’s body rather than with hemostatic devices and the buffer forming part of a hemostatic device. In response to applicant's argument that Hadian is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, while Hadian is not explicitly directed to a hemostatic device, Hadian is directed to a device for delivering or pumping liquid i.e., an injector which is in the same field of endeavor as the injector 200 of applicant’s invention. Thus, Hadian is analogous to a specific feature of a hemostatic device, an injector.
Further, the clip of Hadian is reasonably pertinent to the particular problem with which the inventor was concerned. For example, the securing member i.e., clip of applicant’s invention easily secures an injection member for injecting a fluid into an inflatable member to a cover member and preventing the device and the inflatable member from being displaced or the like when the injection member is secured to the cover member ([0011] of applicant’s specification). Thus, applicant’s problem is a loose tube and injection member unsecured that may be displaced by movement of a patient. Hadian is similarly concerned with providing “a pump clip for a fluid infusion device [injection member] that securely couples the fluid infusion device to the user while reducing a likelihood of damage to the pump clip and/or fluid infusion device from accidental or unintentional displacement of the fluid infusion device” ([0007]). Accordingly, Hadian is reasonably pertinent to the particular problem with which the inventor was concerned and the reasons and rationale that serve as the basis for employing the clip taught by Hadian exists for the hemostatic instrument of Hioki.
Applicant argues the claims state that the coupling portion is configured to permit insertion of a part of the cover member between the main body and the claw portion while Hadian’s clip is specifically configured to be clipped to the patient’s clothing. However, the cover member of Hioki is worn on the hand of a patient similar to a glove i.e., clothing. One of ordinary skill in the art would understand and recognize that the clip of Hioki that is configured to be clipped to clothing would also be fully capable of being clipped to the cover member of Hioki, which is a thin strip of fabric worn by a patient.
Applicant argues that the record lacks findings of fact establishing that the ordinarily skilled artisan would have known that Hadian’s pump clip should be applied at the particular location specified in claims 1 and 18 - at the buffer 202. The examiner respectfully disagrees. The buffer 202 is the largest and most proximal portion of the injector member that is permanently coupled to the hemostatic device of Hioki via tube 203; thus, the largest loose portion of the injector member that may get displaced while the hemostatic device of Hioki is worn by a patient. Accordingly, one of ordinary skill in the art would have looked to the buffer and equated the buffer 202 with the injection member of Hadian to effectively clip and secure the loose buffer 202 and tube 203 to the patient while wearing the hemostatic device.
With respect to claim 1, applicant argues there is no disclosure of the relationship of the width of the claw portion being smaller than the width of the main body at a position where the claw portion overlaps the main body in Hioki or Hadian. The examiner respectfully disagrees. Hadian teaches a width of the claw portion (134) is smaller than a width of the main body (120 and 104) at a position where the claw portion overlaps the main body in the plan view (see for example, Fig. 8 in which 104 would fill in the space below 120; Fig. 9E). Annotated Fig. 8 has been provided below for additional clarification.
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With respect to claim 18, applicant argues the relationship of the inclined portion of the main body of the securing member is located on the proximal side of the distal end of the claw portion is not disclosed in Hadian. The examiner respectfully disagrees. For clarification purposes, annotated Fig. 8 is provided below to clearly show the inclined portion of the main body relative to the proximal side of the distal end of the claw portion.
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Applicant further argues Hadian does not disclose or suggest configuring a main body and claw portion of a securing member in the manner recited in claim 18. The examiner respectfully disagrees. Annotated Fig. 8 below has been provided to clearly identify the outer surface of the claw portion and main body as well as the gap therebetween and the inclined portion. When the clip 134 is open, the gap or slot 260 becomes larger and the inclined portion is open to the gap so that the cover member could be guided along the inclined portion toward the gap during insertion of the cover member into the gap.
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With respect to claim 22, applicant argues that the covering member 110 in Hioki’s hemostatic instrument would not be able to contact the outer surface of the buffer 202 in Hioki’s hemostatic device, rather, the cover member would contact the clip pivot base 128 shown in Fig. 3 of Hadian. However, the buffer 202 of Hioki is not intended to be the claimed main body of the securing member. Instead, the combination of the clip base 120 and the housing 104 of Hadian is interpreted as the claimed main body of the securing member. Thus, in the modification, the clip base 120 of Hadian would be attached to the buffer 202 of Hioki rather than the housing 104. Claim 22 requires a portion of the outer surface of the main body and a portion of the outer surface of the claw portion to face one another so that the portion of the outer surface of the claw portion and the portion of the outer surface of the main body that face one another are both contactable by the part of the cover member inserted in the gap and the clip pivot base 128 is the outer surface of the main body of Hadian. Thus, the cover of modified Hadian would contact both the inner surface of the claw portion at the second side 264 and the clip pivot base 128 of Hadian i.e., the main body.
Applicant’s arguments with respect to claim(s) 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Further, it is the examiner’s position that the claw 134 is at least fixed relative to the main body 120, 104 of Hadian when no force is applied to the curved portion 270 due to the bias of the spring 130 ([0077]).
For at least the reasons set forth above, applicant’s arguments over Hioki in view of Hadian are not found persuasive.
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: coupling portion in claims 1, 7, 12, 18 and 22.
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 23 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.
Claim 23 recites “wherein the claw portion includes a most distal end portion that is positionally fixed relative to the main body.” For support, applicant points to Figs. 11-16 of the present application illustrating the fixed nature of the most distal end portion of the claw portion 233/234. Firstly, Figs. 11-16 are directed to non-elected Species A as noted in the Election/Restriction requirement mailed 1/09/2026. Secondly, the figures alone do not provide sufficient support for a distal most end portion of the claw portion being positionally fixed relative to the main body. For example, as shown in the transition between Figs. 15 and 16, when the sheet material 120 of the cover member is inserted between the claw portion 234 and the main body 231, a larger gap appears between the claw portion 234 and the main body 234 in Fig. 16 than in Fig. 15. Further, paragraph [0228] explicitly contradicts a most distal end portion that is positionally fixed relative to the main body as the specification recites “the securing member can be partially or entirely made of a flexible material in order to reduce a load on the patient's body wearing the hemostatic device or to improve contact with skin at the time of being worn. Furthermore, the securing member may be configured to include a clip structure that enables a distance between the claw portion and the main body to be variable using a resilient force or the like of an elastic member. When the securing member is configured to have the clip structure, the securing member and the cover member can be easily secured and released by opening and closing the clip.” In other words, the paragraph explicitly discloses wherein the claw portion includes a most distal end portion that is variable relative to the main body rather than fixed. Accordingly, claim 23 includes new matter.
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.
Claim 19 is 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.
Claim 19 recites “a gap between the main body and the claw portion” in lines 5-6. Claim 19 depends from claim 18 which recites “a gap exists between the outer surface of the claw portion and the outer surface of the main body” in lines 19-20. It is unclear if the gap of claim 19 is intended to be the same or in addition to that of claim 18. For examination purposes, the gap of claim 19 is interpreted as the same gap of claim 18. Appropriate clarification is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 6-7, 18-20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hioki et al. (WO 2020/111184) in view of Hadian et al. (US 2018/0064868 A1).
Regarding claim 1, Hioki discloses a hemostatic device (hemostatic instrument 100; Fig. 1) for stopping bleeding at a puncture site on a patient (abstract), the hemostatic device comprising: a cover member (covering member 110) configured to cover the puncture site on the patient (Figs. 1, 8); an inflatable member (expanding member 170) connected to the cover member (Figs. 1, 6-7) and configured to be inflated to compress the puncture site (Figs. 13-14); an injection member (including injection part 201 and tube 203) connected to the inflatable member (170) and configured to inject fluid into the inflatable member to inflate the inflatable member (as the injection part 201 injects fluid into the expansion member 170; page 13, paragraph 6 of the attached English translation); the injection member including a connector portion (201) connectable to a source of the fluid (syringe; page 13, paragraph 7 of the attached English translation) to be introduced into the inflatable member and a tube (203) in fluid communication with both the inflatable member and the connector portion so that when the connector portion is connected to the source of the fluid, the fluid from the source of the fluid can be introduced into the inflatable member (page 13, paragraphs 6-11 of the attached English translation).
Hioki discloses a main body (buffer member 202), but fails to disclose a securing member configured to secure the injection member to the cover member; the securing member including a main body connecting the connector portion and the tube, a claw portion extending parallel to the main body toward the inflatable member and overlapping the main body as seen in a plan view, and a coupling portion coupling the claw portion and the main body to one another and configured to permit insertion of a part of the cover member between the main body and the claw portion; and a width of the claw portion is smaller than a width of the main body at a position where the claw portion overlaps the main body in the plan view.
However, Hadian teaches a securing member (pump clip 100; Fig. 1) for an injection member (fluid infusion device 102; Fig. 1A), the securing member configured to secure the injection member to a cover member (belt 284 or strap; [0079]; Fig. 9E); the securing member including a main body (clip base 120 and housing 104) connecting a proximal (106) and distal end (108) of the injection member (102), a claw portion (clip 134) extending parallel to the main body (Fig. 1) toward the distal end and overlapping the main body as seen in a plan view (Fig. 1), and a coupling portion (interpreted under 112(f) as an arm between the claw portion and the main body and spring cover 154 and/or hinge pin 126 is/are an arm between clip 134 and housing 104) coupling the claw portion (134) and the main body (120) to one another and configured to permit insertion of a part of the cover member between the main body and the claw portion (Fig. 9E); and a width of the claw portion (134) is smaller than a width of the main body (120 and 104) at a position where the claw portion overlaps the main body in the plan view (see for example, Fig. 8 in which 104 would fill in the space below 120; Fig. 9E; see annotated Fig. 8 below). Hadian teaches the securing member securely couples the injection member to the user while reducing a likelihood of damage to the securing member and/or injection member from accidental or unintentional displacement ([0007]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body of Hioki to include the securing member as claimed as taught by Hadian in order to securely couple the injection member to the user while reducing a likelihood of damage to the securing member and/or injection member from accidental or unintentional displacement.
Regarding claim 2, Hioki modified discloses wherein the main body includes an inclined portion (distal portion of clip recess 226 of Hadian; Fig. 8) inclined toward the claw portion (Fig. 8 of Hadian), and the inclined portion extends from a position on a distal side of a distal end of the claw portion to a position on a proximal side of the distal end of the claw portion (Fig. 8 of Hadian).
Regarding claim 3, Hioki modified discloses wherein the main body has a circular or elliptical cross-sectional shape (Fig. 1 of Hadian).
Regarding claim 4, Hioki modified discloses wherein the claw portion (134 of Hadian) includes a flat portion (second side 264 of Hadian; Fig. 8) configured to maintain a part of the cover (284 of Hadian) member in a flat shape in a state where the cover member is positioned between the main body and the claw portion (Fig. 9E of Hadian), and the flat portion faces the main body across a gap (slot 260 of Hadian) located between the main body and the claw portion (Fig. 8 of Hadian).
Regarding claim 6, Hioki modified discloses wherein the main body and/or the claw portion (134 of Hadian) has a projection (clip projection 276 of Hadian) protruding toward a gap (260 of Hadian) located between the main body and the claw portion (Fig. 8 of Hadian).
Regarding claim 7, Hioki modified discloses the invention as claimed above, and Hioki further discloses wherein the cover member (110) includes: a main body (at least a portion of body part 120) positioned in overlying relation to the inflatable member (Fig. 1); a first band body (third arm part 150) extending in a first direction away from the main body of the cover member and configured to be disposed between fingers of a hand of the patient (Fig. 8); a second band body (first arm part 130) extending in a second direction away from the main body (Fig. 8), the second direction being different from the first direction (Fig. 8); and a third band body (second arm part 140) extending away from the main body of the cover member in a direction different from the first direction and the second direction (Fig. 8), the third band body (140) facing the second band body (130) across the inflatable member (Fig. 8). Modified Hioki discloses the claw portion (134 of Hadian) being configured to allow any one of the main body of the cover member, the first band body, the second band body, and the third band body to be positioned between the claw portion and the coupling portion (as the clip 134 of Hadian is suitable for receipt of an article of clothing or item associated with the user, such as a strap; [0079]).
Regarding claim 18, Hioki discloses a hemostatic device (hemostatic instrument 100; Fig. 1) for stopping bleeding at a puncture side on a patient (abstract), the hemostatic device comprising: a cover member (covering member 110) configured to cover the puncture site on the patient (Figs. 1, 8); an inflatable member (expanding member 170) connected to the cover member (Figs. 1, 6-7) and configured to be inflated to compress the puncture site (Figs. 13-14); an injection member (including injection part 201 and tube 203) connected to the inflatable member (170) and configured to inject fluid into the inflatable member to inflate the inflatable member (as the injection part 201 injects fluid into the expansion member 170; page 13, paragraph 6 of the attached English translation); the injection member including a connector portion (201) connectable to a source of the fluid (syringe; page 13, paragraph 7 of the attached English translation) to be introduced into the inflatable member and a tube (203) in fluid communication with both the inflatable member and the connector portion so that when the connector portion is connected to the source of the fluid, the fluid from the source of the fluid can be introduced into the inflatable member (page 13, paragraphs 6-11 of the attached English translation).
Hioki discloses a main body (buffer member 202) positioned between the tube (203) and the connector portion (201) so that both the connector portion and the tube are connected to the main body (Fig. 1), but fails to disclose a securing member configured to secure the injection member to the cover member; the securing member including: a main body positioned between the tube and the connector portion so that both the connector portion and the tube are connected to the main body of the securing member, a claw portion extending parallel with the main body toward the inflatable member, having a distal end and having an outer surface spaced from an outer surface of the main body so that a gap exists between the outer surface of the claw portion and the outer surface of the main body; and a coupling portion that couples the claw portion and the main body to one another and configured to allow insertion of the cover member into the gap between the outer surface of the main body and the outer surface of the claw portion; the main body including an inclined portion that is inclined toward the claw portion; and at least a part of the inclined portion being located at a position on a proximal side of the distal end of the claw portion in the main body so that the cover member is guided along the inclined portion toward the gap during the insertion of the cover member.
However, Hadian teaches a securing member (pump clip 100; Fig. 1) for an injection member (fluid infusion device 102; Fig. 1A), the securing member configured to secure the injection member to a cover member (belt 284 or strap; [0079]; Fig. 9E); the securing member including a main body (clip base 120 and housing 104) connecting a proximal (106) and distal end (108) of the injection member (102), a claw portion (clip 134) extending parallel to the main body (Fig. 1) toward the distal end and overlapping the main body as seen in a plan view (Fig. 1), the claw portion (134) having a distal end (Fig. 8) and having an outer surface spaced from an outer surface of the main body so that a gap exists between the outer surface of the claw portion and the outer surface of the main body (see annotated Fig. 8 below); and a coupling portion (interpreted under 112(f) as an arm between the claw portion and the main body and spring cover 154 and/or hinge pin 126 is/are an arm between clip 134 and housing 104) coupling the claw portion (134) and the main body (120) to one another and configured to permit insertion of a part of the cover member into the gap between the outer surface of the main body and the outer surface of the claw portion (Fig. 9E); the main body (120) including an inclined portion (at proximal end of clip recess 226) that is inclined toward the claw portion (Fig. 8); and at least a part of the inclined portion being located at a position on a proximal side of the distal end of the claw portion in the main body (see annotated Fig. 8 below) so that the cover member is capable of being guided along the inclined portion toward the gap during the insertion of the cover member (when 134 is in an open position). Hadian teaches the securing member securely couples the injection member to the user while reducing a likelihood of damage to the securing member and/or injection member from accidental or unintentional displacement ([0007]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body of Hioki to include the securing member as claimed as taught by Hadian in order to securely couple the injection member to the user while reducing a likelihood of damage to the securing member and/or injection member from accidental or unintentional displacement.
Regarding claim 19, Hioki modified discloses wherein the claw portion (134 of Hadian) includes a flat portion (second side 264 of Hadian; Fig. 8) configured to maintain a part of the cover (284 of Hadian) member in a flat shape in a state where the cover member is positioned between the main body and the claw portion (Fig. 9E of Hadian), and the flat portion faces the main body across a gap (slot 260 of Hadian) located between the main body and the claw portion (Fig. 8 of Hadian).
Regarding claim 20, Hioki modified discloses a width of the claw portion (134 of Hadian) is smaller than a width of the main body (120 and 104 of Hadian) at a position where the claw portion overlaps the main body in the plan view (see for example, Fig. 8 of Hadian in which 104 would fill in the space below 120; Fig. 9E).
Regarding claim 22, Hioki discloses a hemostatic device (hemostatic instrument 100; Fig. 1) for stopping bleeding at a puncture site on a patient (abstract), the hemostatic device comprising: a cover member (covering member 110) configured to cover the puncture site on the patient (Figs. 1, 8) and to be secured to the patient (Figs. 8-10), the cover member (110) including a main portion (at expanding member 170; Fig. 2) and a plurality of band portions (first arm part 130, second arm part 140, and a third arm part 150) extending away from the main portion in different directions (Fig. 2); an inflatable member (expanding member 170) connected to the main portion (Figs. 1, 6-7) and configured to be inflated to compress the puncture site (Figs. 13-14); an injection member (including injection part 201 and tube 203) connected to the inflatable member (170) and configured to inject fluid into the inflatable member to inflate the inflatable member (as the injection part 201 injects fluid into the expansion member 170; page 13, paragraph 6 of the attached English translation); the injection member including a connector portion (201) connectable to a source of the fluid (syringe; page 13, paragraph 7 of the attached English translation) to be introduced into the inflatable member and a tube (203) in fluid communication with both the inflatable member and the connector portion so that when the connector portion is connected to the source of the fluid, the fluid from the source of the fluid can be introduced into the inflatable member (page 13, paragraphs 6-11 of the attached English translation).
Hioki discloses a main body (buffer member 202), but fails to disclose a securing member configured to secure the injection member to the cover member; the securing member including a main body connecting the connector portion and the tube, a claw portion extending parallel to the main body toward the inflatable member and overlapping the main body as seen in a plan view, and a coupling portion coupling the claw portion and the main body to one another to permit insertion of a part of the cover member between the main body and the claw portion; the claw portion having an outer surface and the main body having an outer surface, the claw portion being spaced from the main body so that a gap exists between a portion of the outer surface of the claw portion and a portion of the outer surface of the main body that face one another and so that the portion of the outer surface of the claw portion and the portion of the outer surface of the main body that face one another are both contactable by the part of the cover member after the part of the cover member is inserted between the claw portion and the main body and is positioned in the gap; and a width of the claw portion is smaller than a width of the main body at a position where the claw portion overlaps the main body in the plan view.
However, Hadian teaches a securing member (pump clip 100; Fig. 1) for an injection member (fluid infusion device 102; Fig. 1A), the securing member configured to secure the injection member to a cover member (belt 284 or strap; [0079]; Fig. 9E); the securing member including a main body (clip base 120 and housing 104) connecting a proximal (106) and distal end (108) of the injection member (102), a claw portion (clip 134) extending parallel to the main body (Fig. 1) toward the distal end and overlapping the main body as seen in a plan view (Fig. 1), and a coupling portion (interpreted under 112(f) as an arm between the claw portion and the main body and spring cover 154 and/or hinge pin 126 is/are an arm between clip 134 and housing 104) coupling the claw portion (134) and the main body (120) to one another and configured to permit insertion of a part of the cover member between the main body and the claw portion (Fig. 9E); the claw portion having an outer surface and the main body having an outer surface, the claw portion (134) being spaced from the main body (120, 104) so that a gap (260) exists between a portion of the outer surface of the claw portion and a portion of the outer surface of the main body that face one another and so that the portion of the outer surface of the claw portion and the portion of the outer surface of the main body that face one another are both contactable by the part of the cover member after the part of the cover member is inserted between the claw portion and the main body and is positioned in the gap (see for example, annotated Fig. 8); and a width of the claw portion (134) is smaller than a width of the main body (120 and 104) at a position where the claw portion overlaps the main body in the plan view (see for example, Fig. 8 in which 104 would fill in the space below 120; Fig. 9E; see annotated Fig. 8 below). Hadian teaches the securing member securely couples the injection member to the user while reducing a likelihood of damage to the securing member and/or injection member from accidental or unintentional displacement ([0007]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the main body of Hioki to include the securing member as claimed as taught by Hadian in order to securely couple the injection member to the user while reducing a likelihood of damage to the securing member and/or injection member from accidental or unintentional displacement.
Regarding claim 23, Hioki modified discloses wherein the claw portion (134) includes a most distal end portion that is positionally fixed relative to the main body (at least when curved surface 270 is not depressed by a user due to the bias of spring 130; [0077]).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hioki et al. (WO 2020/111184) in view of Hadian et al. (US 2018/0064868 A1), as applied to claim 1 above, and further in view of Lampropoulos et al. (US 2018/0014832 A1).
Regarding claims 10-12, Hioki modified fails to disclose wherein the main body of the securing member has a cylindrical portion and a tapered end portion, one axially extending part of the claw portion overlying the cylindrical portion of the main body and another axially extending part of the claw portion overlying the tapered end portion of the main body; wherein the tube is connected to the tapered end portion of the main body and extends away from the tapered end portion of the main body; and wherein the main body of the securing member has a cylindrical portion and a tapered portion, the coupling portion of the securing member being fixed to the cylindrical portion of the main body, and the claw portion projecting away from the coupling portion toward the tube.
However, Lampropoulos teaches a hemostatic device (compression device 100; Figs. 1-6) comprising an injection member (including proximal and distal ends of valve 140) configured to inject fluid into an inflatable member (inflatable chamber 126) including a connector portion (proximal end of 140) and a tube (tubing 135); a main body (cylindrical and distal tapered portion of valve 140), wherein the main body has a cylindrical portion (proximal portion) and a tapered distal end portion (Figs. 2, 6); wherein the tube (135) is connected to the tapered end portion of the main body (Fig. 2) and extends away from the tapered end portion of the main body (Fig. 2).
Hadian teaches one axially extending part of the claw portion (134) overlying the proximal portion of the main body (104, 102) and another axially extending part of the claw portion overlying the distal end portion of the main body (Fig. 9E); the coupling portion (154) of the securing member being fixed to the proximal portion of the main body (Fig. 2), and the claw portion (134) projecting away from the coupling portion toward the tube (Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the main body to include a proximal cylindrical portion and a distal tapered portion such that one axially extending part of the claw portion overlies the cylindrical portion of the main body and another axially extending part of the claw portion overlying the tapered end portion of the main body; wherein the tube is connected to the tapered end portion of the main body and extends away from the tapered end portion of the main body; the coupling portion of the securing member is fixed to the cylindrical portion of the main body, and the claw portion projects away from the coupling portion toward the tube in light of the teachings of Lampropoulos and Hadian. Changing the shape of the main body is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed main body was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
