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, claims 1-15 in the reply filed on 11/25/2025 is acknowledged. The traversal is on the ground(s) that the stated reason for the restriction is improper. This is not found persuasive because the two groups have separate classification. Group I (claims 1-15) is drawn to a device, classified in C12M35/00, while Group II (claims 16-20) is drawn to method, classified in C12N15/89. A separate classification thereof qualifies as establishing burden for distinct inventions (See MPEP § 808.02). Further, Applicants’ attention is drawn to the fact that the search for method claims requires the identification of processing steps, while the search for apparatus claims requires the identification of structural elements. Further, as discussed in the restriction requirement, the inventions are distinct if it can be shown that the apparatus as claimed can be used to practice another and materially different process (see MPEP § 806.05(e)). The examiner indicated that the apparatus can be used to lyse cells instead of transfecting cells. Thus, the inventions are distinct and therefore the restriction requirement is proper. The requirement is still deemed proper and is therefore made FINAL. Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the 1) a ring is retrofit to a macrocarrier launch assembly of the biolistic particle delivery system (claims 1, 11), 2) the elongated body tapers from an initial thickness greatest at the location where the ring meets the top of the cylindrical body to a terminal thickness less than the initial thickness, and 3) wherein the biolistic particle delivery system comprises a bombardment chamber, connective tubing attached to a vacuum source, a helium regulator, and a solenoid valve (claim 13), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-15 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 the limitation "the flow" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 2-10 and 12-15 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claims 1 and 11 recite the limitation "the cylindrical body." There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the claim to recite -- the body -- or define a cylindrical body earlier in the claim.
The term “substantially” in claim 9 is a relative term which renders the claim indefinite. The term “substantially” 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.
The term “high-pressure” in claim 11 is a relative term which renders the claim indefinite. The term “high-pressure” 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 11 recites the limitation "the attachment of claim 1 located at a second end of the gas acceleration tube" in line 5. However, it is unclear how the biolistic particle delivery system as recited in claim 1 is related to the biolistic particle delivery system as recited in claim 11. Further, it is unclear as to which element of the biolistic particle delivery system the ring should be retrofitted.
Appropriate correction is required.
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, 4 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (already of record; "An improved biolistic delivery and analysis method for evaluation of DNA and CRISPR-Cas delivery efficacy in plant tissue." Scientific Reports 11.1 (2021): 7695) (hereinafter “Miller”).
Regarding claims 1, 4 and 9, it is noted that while the invention contains a biolistic particle delivery system, the biolistic particle delivery system is not positively recited in the instant claims.
Regarding claim 1, Miller discloses an attachment for a biolistic particle delivery system that confines the flow of particles to a barrel comprising: an elongated body with a central cavity that defines a major flow path passing through (see FIG. 1B of Miller, annotated and reproduced below); and
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a ring located at a top of the cylindrical body, said ring having a diameter greater than a diameter of the cylindrical body (see annotated FIG. 1B above); wherein the ring is retrofit to a macrocarrier launch assembly of the biolistic particle delivery system (the ring of the attachment of Miller is structural the same as the instant attachment and thus considered to be fully capable to be “retrofit to a macrocarrier launch assembly of the biolistic particle delivery system”).
Furthermore, it is noted that the recitation of functional language "for a biolistic particle delivery system that confines the flow of particles to a barrel" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed attachment and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 4, Miller further discloses wherein the major flow path is divided into more than one major flow path by one or more dividers (see annotated FIG. 1B above).
Regarding claim 9, the flow of particles is material worked on and not an element of the claimed attachment. Further, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115.
Therefore, Miller meets and anticipates the limitations set forth in claim(s) 1, 4 and 9.
Claims 1, 4 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kale et al. (already of record, US 2009/0011510; hereinafter “Kale”).
Regarding claims 1, 4 and 9-10, it is noted that while the invention contains a biolistic particle delivery system, the biolistic particle delivery system is not positively recited in the instant claims.
Regarding claim 1, Kale discloses an attachment for a biolistic particle delivery system that confines the flow of particles to a barrel comprising: an elongated body with a central cavity that defines a major flow path passing through (see FIG. 1A of Kale, annotated and reproduced below); and
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a ring located at a top of the cylindrical body, said ring having a diameter greater than a diameter of the cylindrical body (see annotated FIG. 1A above); wherein the ring is retrofit to a macrocarrier launch assembly of the biolistic particle delivery system (see [0013], [0042], claim 1). Furthermore, it is noted that the recitation of functional language "for a biolistic particle delivery system that confines the flow of particles to a barrel" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed attachment and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 4, kale further discloses wherein the major flow path is divided into more than one major flow path by one or more dividers (elongated body includes double-barreled defined by the elongated body and a separator 60 within the elongated body; see FIG. [0036]).
Regarding claim 9, the flow of particles is material worked on and not an element of the claimed attachment. Further, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115.
Regarding claim 10, kale further discloses wherein the attachment is symmetrical about at least an X-axis and a y-axis and is asymmetrical about a z-axis, said z-axis being defined by an axial axis traversing a longitude of the elongated body (see FIG. 1).
Therefore, Kale meets and anticipates the limitations set forth in claim(s) 1, 4 and 9-10.
Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rinberg et al. (already of record; "Pneumatic capillary gun for ballistic delivery of microparticles"; hereinafter “Rinberg”).
Regarding claims 1 and 9, it is noted that while the invention contains a biolistic particle delivery system, the biolistic particle delivery system is not positively recited in the instant claims.
Regarding claim 1, Rinberg discloses an attachment for a biolistic particle delivery system that confines the flow of particles to a barrel comprising: an elongated body with a central cavity that defines a major flow path passing through (see annotated FIG. 1 below);and
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a ring located at a top of the cylindrical body, said ring having a diameter greater than a diameter of the cylindrical body (see annotated FIG. 1 above); wherein the ring is retrofit to a macrocarrier launch assembly of the biolistic particle delivery system (the ring of the attachment of Rinberg is structural the same as the instant attachment and thus considered to be fully capable to be “retrofit to a macrocarrier launch assembly of the biolistic particle delivery system”). Furthermore, it is noted that the recitation of functional language "for a biolistic particle delivery system that confines the flow of particles to a barrel" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed attachment and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 9, the flow of particles is material worked on and not an element of the claimed attachment. Further, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115.
Therefore, Rinberg meets and anticipates the limitations set forth in claim(s) 1 and 9.
Claims 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kale (already of record, US 2009/0011510), and as evidenced by Applicant’s disclosure.
Regarding claim 11, Kale discloses a biolistic particle delivery system comprising: a gas acceleration tube (Kale discloses the use of well-known PDS-1000/He system which includes a gas acceleration tube as evidenced by Applicant’s disclosure; see Kale at [0036], [0054], and Applicant’s disclosure at [0018], [0030], FIG. 6B); a source of high-pressure gas operatively connected to a first end of the gas acceleration tube (Kale discloses the use of well-known PDS-1000/He system which includes a gas acceleration tube as evidenced by Applicant’s disclosure; see Kale at [0036], [0054]; and Applicant’s disclosure at [0018], [0029], FIG. 6B); and
an elongated body with a central cavity that defines a major flow path passing through (see FIG. 1A of Kale, annotated and reproduced below);
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a ring located at a top of the cylindrical body, said ring having a diameter greater than a diameter of the cylindrical body (see annotated FIG. 1A above); wherein the ring is retrofit to a macrocarrier launch assembly of the biolistic particle delivery system (see [0036], claim 1); and the attachment is located at a second end of the gas acceleration tube (Kale discloses the use of well-known PDS-1000/He system which includes a gas acceleration tube as evidenced by Applicant’s disclosure; see Kale at [0036], and Applicant’s disclosure at [0018], [0021], FIG. 6B). See also [0013], [0025] and [0037].
Regarding claim 12, Kale further discloses a screen that allows only the biolistic particles to impact an intended target (kale at [0036]).
Regarding claim 13, Kale further discloses wherein the biolistic particle delivery system comprises a bombardment chamber, connective tubing attached to a vacuum source, a helium regulator, and a solenoid valve (Kale discloses the use of well-known PDS-1000/He system which includes a bombardment chamber, connective tubing attached to a vacuum source, a helium regulator, and a solenoid valve, as evidenced by Applicant’s disclosure; see Kale at [0036], and Applicant’s disclosure at [0010]-[0011], FIG. 6B).
Regarding claim 14, Kale further discloses a rupture disk ([0054]).
Regarding claim 15, Kale further discloses wherein the biolistic particle delivery system is a helium driven gene gun (Kale at [0032] and [0036]-[0037]).
Therefore, Kale meets and anticipates the limitations set forth in claim(s) 11-15.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kale as applied to claim 4 above.
Regarding claim 2, Kale discloses the attachment according to claim 1 as set forth above. Kale discloses wherein the elongated body is a hollow cylinder with a length (see FIG. 1A), but does not explicitly disclose wherein the length is between one and a half times and two times (1.5x to 2x) greater than a diameter of the elongated body. However, Kale does disclose wherein the length and diameter of the attachment can be modified to suit the target specimen ([0037], [0041]). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimensions of the elongated to body of Kale to comprise any dimensions including the claimed dimensions. One of ordinary skill in the art would have made said modification because Kale discloses that the length and diameter of the elongated body can be modified to suit the target specimen ([0037], [0041]). Furthermore, it’s noted that the courts have held where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 IV. A.
Regarding claim 3, Kale does not explicitly disclose wherein the elongated body tapers from an initial thickness greatest at the location where the ring meets the top of the cylindrical body to a terminal thickness less than the initial thickness. However, since the instant specification is silent to unexpected results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to change the thickness of the elongated body to comprise the claimed thickness, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
Regarding claim 5, Kale discloses the claimed one or more dividers extending from a bottom of the elongated to body to an inner portion of the elongated body (FIG. 1A-B: separator 60 is slot 50; [0036]), but does not explicitly disclose wherein the one or more dividers begin at the top of the cylindrical body and extend only to a depth at or within the elongated body. However, Kale does disclose wherein two barrels separated by the one or more divider (separator) extend from a top of the cylindrical body and extend only to a depth at or within the elongated body (see FIGS. 1A-B). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elongated body of Kale such that one or more divider (separator) extend from a top of the cylindrical (elongated) body and extend only to a depth at or within the elongated body, since the two barrels of Kale extend from a top of the cylindrical body and extend only to a depth at or within the elongated body. One of ordinary skill in the art would have made said modification for the purpose of enhancing the prevention of accidental spread of particles from one barrel to the other, as disclosed by Kale ([0036]).
Regarding claim 6, Kale discloses wherein each of the more than one major flow path is defined by a cavity shape having at least one curved wall and at least one planar wall (FIG. 1A: planar wall (slit 50) and sidewall).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Miller as applied to claim 4 above.
Regarding claim 7, Miller discloses the attachment according to claim 4 as set forth above. Miller discloses wherein the major flow path is divided into more than one major flow path by one or more dividers that begin at an inner portion of the cylindrical body and extend to a depth beyond the elongated body (see FIG. 1B), thereby acting as fins to help guide flow even as particles have exited the central cavity (see FIG. 1B). Miller, however, does not explicitly disclose wherein the one or more dividers begin at the top of the cylindrical body. However, Miller discloses wherein the one or more dividers are employed to separate two barrels within the attachment (see FIG. 1, and page 2). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more dividers of the elongated body of Miller such that one or more divider (separator) extend from a top of the cylindrical (elongated) body. One of ordinary skill in the art would have made said modification for the purpose of enhancing the prevention of accidental spread of particles from one barrel to the other.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799