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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
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.
Claim 4 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 4 recites the limitation "the one or more dividers" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 8-9 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 8-9, it is noted that while the invention contains a biolistic particle delivery system and a barrel, the biolistic particle delivery system and the barrel are not positively recited in the instant claims.
Regarding claim 1, Miller discloses an attachment for a biolistic particle delivery system configured to confine a flow of particles to a no more than one barrel, said barrel having an inlet at one end and an outlet at the other (attachment of Miller is capable of confining a flow of particles to a no more than one barrel having an inlet at one end and an outlet at the other), comprising: an elongated body with (i) a solid, peripherical surface from the one end to the other and (ii) a central cavity that defines a major flow path for passing and accelerating pressurized gas and particles therethrough (see FIG. 1B of Miller, annotated and reproduced below); and
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a ring located at a top of the elongated body, said ring having a diameter greater than a diameter of the elongated body (see annotated FIG. 1B above); wherein the ring is retrofit to a microcarrier 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 microcarrier launch assembly of the biolistic particle delivery system”).
Furthermore, it is noted that the recitation of functional language “to confine a flow of particles to a no more than one 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 claims 4 and 8, 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 8-9.
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 and barrel, the biolistic particle delivery system and the barrel are not positively recited in the instant claims.
Regarding claim 1, Rinberg discloses an attachment for a biolistic particle delivery system configured to confine a flow of particles to a no more than one barrel, said barrel having an inlet at one end and an outlet at the other (attachment of Rinberg is capable of confining a flow of particles to a no more than one barrel having an inlet at one end and an outlet at the other), comprising: an elongated body with (i) a solid, peripherical surface from the one end to the other and (ii) a central cavity that defines a major flow path for passing and accelerating pressurized gas and particles therethrough (see annotated FIG. 1 below);and
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a ring located at a top of the elongated body, said ring having a diameter greater than a diameter of the elongated body (see annotated FIG. 1 above); wherein the ring is retrofit to a microcarrier 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 microcarrier launch assembly of the biolistic particle delivery system”). Furthermore, it is noted that the recitation of functional language "to confine a flow of particles to a no more than one 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 1, 9 and 22 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 claims 1 and 9, it is noted that while the invention contains a biolistic particle delivery system and a barrel, the biolistic particle delivery system and the barrel are not positively recited in the instant claims.
Regarding claim 1, Kale discloses an attachment for a biolistic particle delivery system configured to confine a flow of particles to a no more than one barrel, said barrel having an inlet at one end and an outlet at the other (attachment of Kale is capable of confining a flow of particles to a no more than one barrel having an inlet at one end and an outlet at the other), comprising: an elongated body with (i) a solid, peripherical surface from the one end to the other and (ii) a central cavity that defines a major flow path for passing and accelerating pressurized gas and particles therethrough (see FIG. 1A of Kale, annotated and reproduced below);
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and a ring located at a top of the elongated body, said ring having a diameter greater than
a diameter of the elongated body (FIG. 1A); wherein the ring is retrofit to a microcarrier launch assembly of the biolistic particle
delivery system (the ring of the attachment of Kale is structural the same as the instant attachment and thus considered to be fully capable to be “retrofit to a microcarrier launch assembly of the biolistic particle delivery system”; see also [0036] and claim 1 of Kale). Furthermore, it is noted that the recitation of functional language “to confine a flow of particles to a no more than one 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.
Regarding claim 22, Kale discloses wherein the elongated body has a diameter between eighteen and twenty-two millimeters ([0037]) and a length between thirty and fifty-five millimeters ([0037]).
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 [0013], [0025], [0036]-[0037], [0054], and Applicant’s disclosure at [0018], [0030], FIG. 6B); a source of pressurized gas operatively connected to a first end having an inlet 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, the gas acceleration tube having an inlet; see Kale at [0036], [0054]; and Applicant’s disclosure at [0018], [0029], FIG. 6B); and an attachment located at a second end having an outlet of the gas acceleration tube, the attachment (see Kale at [0036], and Applicant’s disclosure at [0018], [0021], FIG. 6B). See also [0013], [0025] and [0037]) comprising: an elongated body having (i) no inlets or outlets located at positions other than the first end and the second end (see FIG. 1A: elongated body has no other inlets/outlets other than top inlet and bottom outlet) (ii) a central cavity that defines a major flow path therethrough, wherein a pressure of the pressurized gas is, at least, maintained from the first end to the second end (see FIG. 1A of Kale, annotated and reproduced below); and
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a ring located at a top of the elongated body, said ring having a diameter greater than a diameter of the elongated body (FIG. 1A); and wherein the ring is configured to be retrofit to a microcarrier launch assembly of the biolistic particle delivery system (the ring of the attachment of Kale is structural the same as the instant attachment and thus considered to be fully capable to be “retrofit to a microcarrier launch assembly of the biolistic particle delivery system”; see also [0036] and claim 1 of Kale).
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, vacuum tubing, a helium regulator, and a solenoid valve (Kale discloses the use of well-known PDS-1000/He system which includes a bombardment chamber, 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, 5-6 and 21 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 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 elongated body and extend 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 elongated body and extend 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 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 elongated 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).
Regarding claim 21, Kale meets the limitation “wherein the elongated body is made from an inert material constructed to withstand pressure used within the biolistic particle delivery system,” since the elongated body of Kale is used in biolistic particle delivery system. Kale does not explicitly disclose wherein the material is an inert material. However, 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 have modified the elongated body of Kale to comprise inert material because the use of inert nontoxic material with biological material is well known in the art. One of ordinary skill in the art would have made said modification in order to prevent the material of the elongated body to interacting with components of the biological materials. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot in view of the new ground of rejection.
In response to the Applicant’s argument that Miller, Kale and Rinberg do not disclose a single barrel (Remarks at page 11), Applicant’s argument is not persuasive. Intendent claim 1 does not positively recite a single barrel. Rather, claim 1 requires the attachment capable of confining a flow of particles to no more than one barrel. That is, the barrel itself is not required by the claim.
In response to the Applicant’s argument regarding the rejection of claim 7 (Remarks at pages 14 to 13), Applicant’s argument is not persuasive. The only reference relied upon for disclosing the features of claim 7 is modified Miller. In response to applicant's argument that the dividers of Miller are not for flow-guiding (Remarks at page 13), the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The dividers of Miller intrinsically guide the particle flowing within the device. Further, Miller explicitly 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. As such, Applicant’s argument is not persuasive.
In response to the Applicant’s argument the claims 1 and 11 no incorporate fins/dividers features (Remarks page 16), independent claims 1 and 11 as currently presented do not require fins/dividers features.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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