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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted 10/16/24 and 2/3/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 15 is objected to because of the following informalities: claim 15 recites the term “them.” The Examiner suggests amending the claim to avoid this terminology. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-20 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.
Claim 1 recites that “each of the clip storage areas is provided with an opening through which an applicator can be inserted…” As currently written, an applicator is not positively recited in claim 1. Claim 18 recites: “a protective member configured to protect a distal end of the applicator, wherein, when the protective member opens the lid, the protective member separates from the applicator, and the applicator from which the protective member has been removed is inserted into the clip storage area.” Claim 18 is reciting additional features of the applicator. Claim 18 is indefinite because it is unclear if the Applicant’s invention is directed to just a cartridge system or to a cartridge system and an applicator. Appropriate correction is required.
Claims 19 and 20 are dependent on rejected claim 18, thus are also rendered indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 20 is dependent on claim 19, and contains the same limitations as claim 19. Thus, claim 20 fails to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samuels et al. (US 4,146,130) (“Samuels”).
Regarding claim 1, Samuels discloses (Figures 1-15) a cartridge system, comprising: a main body portion (88) having a plurality of clip storage areas (92), wherein each of the clip storage areas stores a clip (80), and each of the clip storage areas is provided with an opening through which an applicator can be inserted and a lid (94) for independently opening and closing the opening (Column 5, lines 19-45).
Regarding claim 5, Samuels discloses that the clip can be stored in the clip storage area before the lid is attached to the opening (Column 5, lines 9-12).
Regarding claim 18, an applicator with a protective member configured to protect a distal end of the applicator is capable of opening the lid, and separating from the applicator when the applicator is inserted into the clip storage area. NOTE: the applicator is not positively recited in claim 1.
Claims 1-3, 7, 8, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jewusiak et al. (US 4,294,355) (“Jewusiak”).
Regarding claim 1, Jewusiak discloses (Figures 1-5) a cartridge system, comprising: a main body portion (11) having a plurality of clip storage areas (19), wherein each of the clip storage areas stores a clip (30), and each of the clip storage areas is provided with an opening (24) through which an applicator can be inserted and a lid (12) for independently opening and closing the opening (Figure 5; Column 3, lines 37-44).
Regarding claim 2, Jewusiak discloses the clip storage area is maintained in a sterile state when the opening is closed by the lid (Column 4, lines 14-24).
Regarding claim 3, Jewusiak discloses (Figure 1) a base (11) capable of supporting the main body portion with the opening disposed at a position where the applicator can be inserted (Column 2, lines 58-61).
Regarding claim 7, Jewusiak discloses (Figure 5) that the lid (12) is a seal that closes the opening (24), and the opening is opened when the applicator breaks through the seal and enters the clip storage area (Column 2, lines 62-68; Column 3, lines 27-36).
Regarding claim 8, Jewusiak discloses (Figures 2 and 5) a mark (22) that indicates a position where the applicator breaks through the seal.
Regarding claim 18, an applicator with a protective member configured to protect a distal end of the applicator is capable of opening the lid, and separating from the applicator when the applicator is inserted into the clip storage area. NOTE: the applicator is not positively recited in claim 1.
Claims 1 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mericle (US 4,361,229).
Regarding claim 1, Mericle discloses (Figures 1-4d) a cartridge system, comprising: a main body portion (70) having a plurality of clip storage areas, wherein each of the clip storage areas stores a clip (75), and each of the clip storage areas is provided with an opening through which an applicator can be inserted (Figures 4b and 4c) and a lid (81) for independently opening (Figures 4b, 4c) and closing (Figure 4a) the opening (Column 4, line 32 – Column 5, line 11).
Regarding claim 18, an applicator with a protective member configured to protect a distal end of the applicator is capable of opening the lid, and separating from the applicator when the applicator is inserted into the clip storage area. NOTE: the applicator is not positively recited in claim 1.
Regarding claims 19 and 20, Mericle discloses (Figures 4a-4c) a connecting member (82) that detachably connects the clip (75) and the applicator, wherein the connecting member is disposed in the clip storage area together with the clip, and the applicator inserted into the clip storage area is connected to the clip via the connecting member (Column 4, lines 55-58).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4, 6, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Jewusiak et al. (US 4,294,355) (“Jewusiak”) in view of Esposito et al. (US 6,044,971) (“Esposito”).
Regarding claim 4, Jewusiak discloses the invention substantially as claimed. However, Jewusiak fails to disclose the clip can be stored in the clip storage area when the main body portion and the base are separated. Jewusiak fails to disclose that the main body portion and the base are separable.
In the same field of endeavor, Esposito teaches (Figures 1-18) a cartridge system, comprising: a main body portion (14) having a plurality of clip storage areas (16), wherein each of the clip storage areas stores a clip (26); and a base (40) capable of supporting the main body portion. Esposito teaches (Figures 7-9 and 18) that the main body portion and the base are separable, and the clip can be stored in the clip storage area when the main body portion and the base are separated (Column 4, lines 19-38; Column 5, lines 39-50).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed intention to modify the main body portion and the base to be separable and to allow the clip to be stored in the clip storage area when the main body portion and the base are separated, as taught by Esposito. This modification would allow a multiplicity of clip cartridges to be attached to the base to provide an integral clip cartridge assembly having the required number of clips for a surgical procedure (Esposito, Column 4, lines 26-30). Further, it will allow the main body portions to be packaged in kits and stored separately from the base portion (Column 5, lines 39-50).
Regarding claim 6, Jewusiak discloses the invention substantially as claimed. However, Jewusiak fails to disclose that the clip can be stored in the clip storage area when a part of the main body portion is removed from the main body portion.
In the same field of endeavor, Esposito teaches (Figures 7 and 8) a cartridge system, comprising: a main body portion (10) having a plurality of clip storage areas (16), wherein each of the clip storage areas stores a clip (26). Esposito teaches that the clip can be stored in the clip storage area when a part (10’) of the main body portion is removed from the main body portion (10).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the main body portion to include a part that can be removed from the main body portion, and for the clip to be stored in the clip storage area when the part of the main body portion is removed from the main body portion, as taught by Esposito. This modification would allow an operator to remove a part of the main body portion to remove clips that are not required for a surgical procedure (Esposito, Column 4, lines 26-29).
Regarding claim 10, Jewusiak discloses the invention substantially as claimed. However, Jewusiak fails to disclose a base, wherein the main body portion has a first body portion and a second body portion, the first body portion has a first clip storage area that is one of the plurality of clip storage areas, the second body portion has a second clip storage area that is another of the plurality of clip storage areas, the base is configured to support the first body portion and the second body portion independently and separably.
In the same field of endeavor, Esposito teaches (Figures 7-9) a cartridge system, comprising: a main body portion (10, 10’) wherein the main body portion has a first body portion (10) and a second body portion (10’), the first body portion has a first clip storage area (16) that is one of the plurality of clip storage areas, the second body portion has a second clip storage area (16) that is another of the plurality of clip storage areas. Esposito further teaches a base (40), wherein the base is configured to support the first body portion and the second body portion independently (within slot 42) and separably (Column 4, lines 19-38).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge system disclosed by Jewusiak such that the main body portion has a first body portion and a second body portion, the first body portion has a first clip storage area that is one of the plurality of clip storage areas, the second body portion has a second clip storage area that is another of the plurality of clip storage areas, and to include a base configured to support the first body portion and the second body portion independently and separably. This modification would allow a multiplicity of clip cartridges to be attached to the base to provide an integral clip cartridge assembly having the required number of clips for a surgical procedure (Esposito, Column 4, lines 26-30). Further, it will allow the main body portions to be packaged in kits and stored separately from the base portion (Column 5, lines 39-50).
Regarding claim 11, Jewusiak as modified by Esposito teaches that the base is configured to support the first body portion and the second body portion with the opening positioned at a position where the applicator can be inserted. As modified, the base supports the first body portion and the second body portion from below. Therefore, an applicator would be able to be inserted into the openings.
Regarding claim 12, Jewusiak discloses the invention substantially as claimed. However, Jewusiak fails to disclose that the main body portion has a first main body portion and a second main body portion, the first main body portion has a first clip storage area that is one of the plurality of clip storage areas, the second main body portion has a second clip storage area that is another of the plurality of clip storage areas, and the first main body portion and the second main body portion are separable.
In the same field of endeavor, Esposito teaches (Figures 7-9) a cartridge system, comprising: a main body portion (10, 10’) wherein the main body portion has a first main body portion (10) and a second main body portion (10’), wherein the first main body portion has a first clip storage area (16) that is one of the plurality of clip storage areas, the second main body portion has a second clip storage area (16) that is another of the plurality of clip storage areas, and the first main body portion and the second main body portion are separable (Column 4, lines 19-38).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge system disclosed by Jewusiak such that the main body portion has a first main body portion and a second main body portion, wherein the first main body portion has a first clip storage area that is one of the plurality of clip storage areas, the second main body portion has a second clip storage area that is another of the plurality of clip storage areas, and the first main body portion and the second main body portion are separable, as taught by Esposito. These modifications would allow a multiplicity of clip cartridges to be attached together to provide an integral clip cartridge assembly having the required number of clips for a surgical procedure (Esposito, Column 4, lines 26-30). Further, it will allow the main body portions to be packaged in kits for storage (Column 5, lines 39-50).
Regarding claim 13, Jewusiak as modified by Esposito above teaches the invention substantially as claimed. However, the combined teaching fails to teach that the first main body portion has a first base capable of supporting the first main body portion with the opening positioned at a position where the applicator can be inserted, and the second main body portion has a second base capable of supporting the second main body portion with the opening positioned at a position where the applicator can be inserted.
Esposito further teaches a first base (40) capable of supporting the first main body portion with the opening positioned at a position where the applicator can be inserted, and a second base (a slotted surgical table) capable of supporting the second main body portion with the opening positioned at a position where the applicator can be inserted (Column 4, lines 32-43).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge system taught by Jewusiak in view of Esposito to further include a first base capable of supporting the first main body portion with the opening positioned at a position where the applicator can be inserted and a second base capable of supporting the second main body portion with the opening positioned at a position where the applicator can be inserted, as further taught by Esposito. This modification would provide fixed locations to support the first main body portion and the second main body portion during a surgical procedure (Esposito, Column 4, lines 32-43).
Regarding claim 14, Jewusiak discloses the invention substantially as claimed. However, Jewusiak fails to disclose the main body portion has a first main body portion and a second main body portion, the first main body portion has a first clip storage area that is one of the plurality of clip storage areas, the second main body portion has a second clip storage area that is another of the plurality of clip storage areas, and the first main body portion and the second main body portion are detachable.
In the same field of endeavor, Esposito teaches (Figures 7-9) a cartridge system, comprising: a main body portion (10, 10’) wherein the main body portion has a first main body portion (10) and a second main body portion (10’), wherein the first main body portion has a first clip storage area (16) that is one of the plurality of clip storage areas, the second main body portion has a second clip storage area (16) that is another of the plurality of clip storage areas, and the first main body portion and the second main body portion are detachable (Column 4, lines 19-38).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge system disclosed by Jewusiak such that the main body portion has a first main body portion and a second main body portion, wherein the first main body portion has a first clip storage area that is one of the plurality of clip storage areas, the second main body portion has a second clip storage area that is another of the plurality of clip storage areas, and the first main body portion and the second main body portion are detachable, as taught by Esposito. These modifications would allow a multiplicity of clip cartridges to be attached together/detached from one another to provide a clip cartridge assembly having the required number of clips for a surgical procedure (Esposito, Column 4, lines 26-30). Further, it will allow the main body portions to be packaged in kits for storage (Column 5, lines 39-50).
Claims 1, 9, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Fischvogt et al. (US 2023/0346378 A1) (“Fischvogt”) in view of Jewusiak et al. (US 4,294,355) (“Jewusiak”).
Regarding claims 1 and 15-17, Fischvogt discloses (Figures 5-12) a cartridge system, comprising: a main body portion (304) having a plurality of clip storage areas (between slots 324/524c in Figures 8/11), wherein each of the clip storage areas stores a clip (318), and each of the clip storage areas is provided with an opening (326) through which an applicator (50) can be inserted (Figure 9B). Fischvogt discloses a storage case (300), wherein the main body portion has a first main body portion and a second main body portion, the first main body portion has a first clip storage area that is one of the plurality of clip storage areas, the second main body portion has a second clip storage area that is another of the plurality of clip storage areas, and the storage case stores the first main body portion and the second main body portion in a manner that allows them to be ejected in sequence (paragraph 0073). Fischvogt teaches that when the applicator (50) is inserted into the first body portion that is disposed at an insertable position where the applicator can be inserted and the clip is loaded into the applicator, the first body portion is ejected from the storage case and the second body portion is disposed at the insertable position (paragraph 0073). Fischvogt discloses (Figure 9B) that the second body portion is disposed inside the storage case (300) when the first body portion is disposed at the insertable position. Fischvogt fails to disclose that each opening is provided with a lid for independently opening and closing the opening.
Jewusiak teaches (Figures 1-5) a cartridge system, comprising: a main body portion (11) having a plurality of clip storage areas (19), wherein each of the clip storage areas stores a clip (30), and each of the clip storage areas is provided with an opening (24) through which an applicator can be inserted and a lid (12) for independently opening and closing the opening (Figure 5; Column 3, lines 37-44).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge system disclosed by Fischvogt such that each opening is provided with a lid for independently opening and closing the opening. This modification will provide a film of paper/plastic/thin sheet of material to hold each clip in position prior to an applicator being inserted into the opening to retrieve a clip and will allow the applicator to penetrate through the film via a perforation/line of weakness to retrieve each clip (Jewusiak, Column 3, line 62 – Column 4, line 2).
Regarding claim 9, Fischvogt as modified by Jewusiak teaches (Figure 8) the clip is stored in a case (322) into which an applicator can be inserted (Figure 9B), and the case is housed in the clip storage area.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771