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 .
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.
Claim Objections
Claims 56, 59, 63, 66, and 73 objected to because of the following informalities:
In claims 56, 59, 66, and 73: “and comprising” should read “, further comprising”
In claim 53: “being” should read “are”
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 64-63 and 66-72 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 54 recites ‘a biopsy needle’ twice in the claim making it unclear if each recitation is meant to refer to the same element or not. For the purposes of examination they will be treated as the same element.
Claim 55 appears to be directed to a method step which makes the claim unclear given it is meant to be an apparatus claim. Thus it appears to create a clarity issue as to what statutory category is intended to be claimed.
Claim 55 recites ‘a needle’ and is dependent back to claim 54 which recites ‘a biopsy needle’ making it unclear if the recitation in claim 55 is meant to refer to that in claim 54 or not.
The term “generally” in claim 55 is a relative term which renders the claim indefinite. The term “generally” 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.
Claim 55 recites ‘wherein supporting of a needle is in a generally fixed position’ and it is unclear what this is meant to mean. It appears there may be a grammatical issue as it appears ‘in a generally fixed position’ modifies and action of ‘wherein supporting’ which is unclear. For examination purposes this will be treated as ‘wherein a needle is supported in a generally fixed position’.
Claim 57 recites ‘a biopsy needle’ and is dependent back to claim 54 which recites ‘a biopsy needle’ making it unclear if the recitation in claim 57 is meant to refer to that in claim 54 or not. For examination purposes they will be treated as the same element.
The term “generally” in claim 57 is a relative term which renders the claim indefinite. The term “generally” 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.
Claim 58 recites the limitation "the motion of movement" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 58 recites the limitation "the axial direction" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 59, the phrase "possibly an" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 59 recites the limitation "the moving" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 59 recites ‘and hence’. The claim(s) are narrative in form. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. Note the format of the claims in the patent(s) cited.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 60 recites the broad recitation “at least one groove”, and the claim also recites “at least two grooves” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 60 recites the limitation "the two grooves" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 60 recites the limitation "the tracks" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 60 recites the limitation "the grooves" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 61 recites ‘each track’ and it is unclear what this is meant to refer to given there was only one track claimed (see claim 58).
Claim 61 recites ‘a beginning and an end’ and it is unclear what this is meant to refer to or be relative to. Examiner suggest the use of the terms ‘proximal’ and ‘distal’.
Claim 62 recites the term ‘its’ and it is unclear what element ‘its’ is meant to refer to.
Claim 62 recites ‘a needle’ and is dependent back to claim 54 which recites ‘a biopsy needle’ making it unclear if the recitation in claim 62 is meant to refer to that in claim 54 or not.
Claim 62 recites ‘same needle’ and is dependent back to claim 54 which recites ‘a biopsy needle’ making it unclear if the recitation in claim 62 is meant to refer to that in claim 54 or not.
The term “generally” in claim 66 is a relative term which renders the claim indefinite. The term “generally” 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.
Claim 67 recites ‘and after that’. The claim(s) are narrative in form. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. Note the format of the claims in the patent(s) cited.
Claim 68 recites the limitation "the motion of movement" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 68 recites the limitation "the needle" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 69 recites the limitation "the motion of movement" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 69 recites the limitation "the axial direction" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 70, the phrase "possibly an" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 70 recites the limitation "the moving" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 70 recites ‘and hence’. The claim(s) are narrative in form. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. Note the format of the claims in the patent(s) cited.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 71 recites the broad recitation “at least one groove”, and the claim also recites “at least two grooves” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 71 recites the limitation "the two grooves" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 71 recites the limitation "the tracks" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 71 recites the limitation "the grooves" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 72 recites ‘each track’ and it is unclear what this is meant to refer to given there was only one track claimed (see claim 58).
Claim 72 recites ‘a beginning and an end’ and it is unclear what this is meant to refer to or be relative to. Examiner suggest the use of the terms ‘proximal’ and ‘distal’.
Claim 73 recites the limitation "the needle" in Lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 54-61 and 64-72 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pastenak et al. (US 2014/0031718).
Regarding claim 54, Pastenak teaches a device for collecting a biological sample from a biopsy needle (Abstract), the device comprising:
a housing (20) suitable for supporting a biopsy needle (10) (Paragraph 0090 including needle base 58 and gun housing 204), and
a cassette (140; Paragraph 0101; “Cassette 140 comprises a cassette base 142 and a cassette cover 144, and configured to hold firmly a sample sheet 146 in between”) comprising an adhering surface (146; Paragraph 0106; “Sample sheet 146 may adhere to a biological tissue”),
wherein the device being configured to collect the biological sample through motions comprising rotation of the cassette about a hinge member (210) defining a pivot axis P and movement of the hinge member within the device (Paragraph 0130; Figures 7A-7B, 7D, 8A-8C; Paragraph 0021).
Regarding claim 55, Pastenak teaches wherein supporting of a needle is in a generally fixed position within the device (Figures 7A-7B and 7D).
Regarding claim 56, Pastenak teaches and comprising a cassette holder (114) for detachably housing the cassette therein (Paragraph 0100).
Regarding claim 57, Pastenak teaches wherein the cassette holder being coupled via the hinge member to a coupling position within the device, and the pivot axis P being configured to be generally parallel to a longitudinal axis X of a biopsy needle supported in the device (Figures 7A-7B and 7D).
Regarding claim 58, Pastenak teaches wherein the motion of movement of the hinge member is along a track formed in the device that extends transverse to the axial direction of the pivot axis P (Paragraphs 0021 and 0091).
Regarding claim 59, Pastenak teaches and comprising at least one groove defining the track, possibly an arched shaped track, and the moving of the hinge member and hence movement of the coupling position is along the track (Paragraphs 0091 and 0135)
Regarding claim 60, Pastenak teaches wherein the at least one groove is at least two grooves and the hinge member is coupled to the two grooves and is movable along the tracks defined by the grooves (Paragraphs 0091 and 0135).
Regarding claim 61, Pastenak teaches wherein each track extends between a beginning and an end, and the device comprising a biasing member for urging the hinge member towards the beginning of the track (Paragraph 0144).
Regarding claim 64, Pastenak teaches a method for collecting a biological sample (Abstract) comprising the steps of:
providing a device comprising a housing and a cassette (see rejection of Claim 1 above),
supporting a biopsy needle in a fixed position within the housing (see rejection of Claim 1 above), and
urging motions within the device that comprise rotating the cassette about a hinge member that defines a pivot axis P and moving the hinge member within the device (Paragraphs 0188-0191; further see rejection of Claim 1 above).
Regarding claim 65, Pastenak teaches wherein the rotation about the hinge member urges an adhering surface of the cassette to engage with the biopsy needle, and moving the hinge member urges relative motion between the biopsy needle and the adhering surface in order to assist in collecting the biological sample from the biopsy needle (Paragraphs 0188-0191).
Regarding claim 66, Pastenak teaches and comprising a cassette holder for detachably housing the cassette therein (see rejection of claim 1 above), wherein the cassette holder being coupled via the hinge member to a coupling position within the device, and the pivot axis P being configured to be generally parallel to a longitudinal axis X of the biopsy needle (Figures 7A-7B and 7D).
Regarding claim 67, Pastenak teaches wherein the collecting of the biological sample comprises first rotation about the hinge member and after that movement of the hinge member (Paragraphs 0129 and 0187-0191).
Regarding claim 68, Pastenak teaches wherein the motion of movement of the hinge member comprises urging rolling of the adhering surface upon the needle (Paragraph 0129).
Regarding claim 69, Pastenak teaches wherein the motion of movement of the hinge member is along a track formed in the device that extends transverse to the axial direction of the pivot axis P (Paragraphs 0021 and 0091).
Regarding claim 70, Pastenak teaches wherein the device comprises at least one groove defining the track, possibly an arched shaped track, and the moving of the hinge member and hence movement of the coupling position is along the track (Paragraphs 0091 and 0135).
Regarding claim 71, Pastenak teaches wherein the at least one groove is at least two grooves and the hinge member is coupled to the two grooves and is movable along the tracks defined by the grooves (Paragraphs 0091 and 0135).
Regarding claim 72, Pastenak teaches wherein each track extends between a beginning and an end, and the device comprising a biasing member for urging the hinge member towards the beginning of the track (Paragraph 0144).
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.
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) 62-63 and 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pastenak et al. (US 2014/0031718) in view of Rebellino et al. (US 2022/0313227).
Regarding claim 62, Pastenak is silent on the blades. Rebellino teaches wherein the cassette comprises one or more blades located above its adhering surface for engaging a needle supported in the device prior to engagement of the adhering surface with same needle (Paragraph 0092; Figure 12A). It would have been obvious to one of ordinary skill in the art to have modified Pastenak with Rebellino because it aids in promoting complete engagement and reducing trauma (Paragraph 0078 of Rebellino).
Regarding claim 63, Pastenak is silent on the blades. Rebellino teaches wherein the one or more blades being resiliently attached to the cassette (Paragraphs 0078 and 0092). It would have been obvious to one of ordinary skill in the art to have modified Pastenak with Rebellino because it aids in promoting complete engagement and reducing trauma (Paragraph 0078 of Rebellino).
Regarding claim 73, Pastenak is silent on the blades. Rebellino teaches and comprising one or more blades located above the adhering surface for engaging the needle prior to engagement of the adhering surface with the needle supported in the device (Paragraph 0092; Figure 12A). It would have been obvious to one of ordinary skill in the art to have modified Pastenak with Rebellino because it aids in promoting complete engagement and reducing trauma (Paragraph 0078 of Rebellino).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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