DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I, Species C in the reply filed on 3/09/2029 is acknowledged. The traversal is on the ground(s) that all the claims in the application can be examined at the same time without serious burden. This is not found persuasive because a careful study of the claimed inventions clearly indicates diverse searches of multiple inventions are required. In addition to the different classifications noted in the election/restriction mailed 1/09/2026, the elected claims require the following text searches for different limitations in which none of the following terms/concepts would be searched for the non-elected claims: “the claw portion has a projection”, “protruding toward a gap”, etc. while the non-elected claims require searches for words along the lines of: “curved”, “second claw portion”, “groove”, “parallel”, “cantilever part”, “positioning”, “wrapping”, “overlying relation” etc. Furthermore, the search and/or examination burden is not limited exclusively to a prior art search but also includes that effort required to apply the art by making and discussing all appropriate grounds of rejection. Multiple inventions, such as those in the present application, normally require additional reference material and further discussion for each additional invention examined. Concurrent examination of multiple inventions would thus typically involve a significant burden even if all searches were coextensive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5, 8-9, 13-17, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/09/2026. It is noted applicant included claims 8-9 as reading on the elected species shown in Fig. 30. However, claim 8 recites “a second claw portion extending parallel to the main body toward the inflatable member and overlapping the main body as seen in the plan view” in lines 4-5, which reads on Species A in Figs. 11-18 rather than Species B. Claim 9 depends from claim 8. Accordingly, claims 8-9 have also been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1, line 12 recites “the fluid source” which should read “the source of the fluid” for consistency purposes. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1, line 18 recites “portion;,” which should read “portion;” for grammatical purposes. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: Claim 18, line 12 recites “the fluid source” which should read “the source of the fluid” for consistency purposes. Appropriate correction is required.
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, 12 and 18.
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 § 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 and 18-20 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) comprising: a cover member (covering member 110) configured to cover a puncture site on a 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 fluid source 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). 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]).
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) comprising: a cover member (covering member 110) configured to cover a puncture site on a 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 fluid source 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 and having a distal end; 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 between the main body and 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.
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 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 (Fig. 8). 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]).
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).
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Olson et al. (US 6,551,273 B1) is noted for teaching clips for catheters (Fig. 17).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771