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 .
Applicant’s amendment and argument of 4/2/26 are entered.
Claims 1, 11-12, and 18 are amended.
Claims 2-10, 13, 15-17, and 20 are canceled.
Claims 21-34 are newly presented.
Claims 1, 11-12, 14, 18-19, and 21-34 are presently pending and are considered herein.
Claim Status, Canceled Claims
In light of the cancelation of Claims 2-10, 13, 15-17, and 20, all rejections/objections thereto, are withdrawn.
Claim Objections
Applicant is advised that should claim 11 be found allowable, claim 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 23 indicates that the mechanical energy that porates the cells comprises a pressure wave. However, a pressure wave is always present, otherwise the mechanical energy is not there. Thus, despite the slight difference in wording, these claims have the same scope.
Applicant is advised that should claim 28 be found allowable, claim 29 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 29 requires heat to be generated by the absorption of optical energy from the laser pulses, by one of the features. However, optical energy is always generated, under the second law of thermodynamics. Thus, despite the slight difference in wording, these claims have the same scope.
Applicant is advised that should claim 11 be found allowable, claim 31 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 31 requires the film to comprise a laser-activated surface. However, Claim 11 requires converting, by the film, optical energy from the laser, into mechanical energy. As such, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 31 be found allowable, claim 32 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 32 requires the cells to be at a distance from the laser-activated surface. However, as they do not exist in the same space, they are always at a distance. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 18 be found allowable, claim 33 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 33 requires at least a portion of the interior substrate be in an active region. However, Claim 18 requires a selective disruption to occur by optical to mechanical energy conversion, by the film. Thus, the film necessarily has an active region.
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.
In light of the amendment, the rejections against Claim 1 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, are withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
In light of the acceptance of the terminal disclaimer filed 4/2/26, the rejections of the claims of record, on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,643,667, are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
In light of the amendments, the rejections of Claims 1, 11-12, 14, and 18-19 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, are withdrawn.
To wit, the medium is now in the independent claims, and the wavelengths for the medium are described.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
In light of the amendment, requiring a cell medium, the rejections of 1, 11-12, 14, and 18-19 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
In light of the amendment, canceling Claim 6, the rejections of Claims 1, 11-12, 14, 18-and 19 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, are withdrawn.
Claim Rejections - 35 USC § 102
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 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) 1, 11-12, 14, 19, and 21-33 are/remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Courvoisier, et al. (2015) “Plasmonic Tipless Pyramid Arrays for Cell Poration”, NanoLetters, 15: 4461-66, as necessitated by amendment.
Claims 1 and 11-12: Courvoisier teaches a gold-film on a pyramid array (e.g., Figure 1). The same was utilized where HeLa cells are seeded on the substrate and grown to confluency (e.g., pp. 4464-65, paragraph bridging). An external laser was utilized to selectively porate (i.e., disrupt) and transfect specific cells, i.e., the upper half of cells in Figures 9A-9D. As regards the new limitation of Claims 1 and 11, added 4/2/26, that the film is a continuous flat layer, and a cell medium in the container, it is further noted that the substrate may be patterned with one or more features that absorb the laser pulses (Claim 28). The pyramids absorb the laser pulses and create the selective poration of the cells (e.g., upper half of cells in Figures 9A-9D). It should be noted this is further backed by the description by Applicant, which is provided in paragraph 2 of page 19, which provides the flat substrate may be patterned to absorb laser radiation or nucleate bubble formation, and these features could simply serve the purpose of promoting bubble nucleation at pre-determined sites, the net effect allowing for a large area to be addressed by a laser pulse and generate bubbles in a highly-repeatable pattern (Id). The essence of this is whether the pattern of Courvoisier meets the limitation of “continuous flat layer”, which, as seen by depending new Claim 28, is patterned with one or more features that absorb the laser pulses. At this point, the Examiner does not see how this does not meet the limitation. Absent reason to believe otherwise, it does.
Claim 14: as the microbubbles are formed (e.g., p. 4464, col. 2, paragraph 3), it is presumed that such forms the pressure wave disrupting the cells, through the formation and contraction of the microbubbles created.
Claim 19: a gold film is utilized (e.g., Figure 1A), which is necessarily a metallic film.
Claim 21: the laser is necessarily q-switched, as it is used with a femtosecond excitiation (e.g., p. 4462, column 2, paragraph 2).
Claim 22: absent reason to believe otherwise, some cargo in the cells also leaves the cell during the poration.
Claim 23: absent reason to believe otherwise, the mechanical energy does comprise a pressure wave.
Claim 24: the light is focused onto points on the film (e.g., p. 4465, left column, first paragraph).
Claim 25: it is taught to use an objective lens to focus the laser (e.g., Id.).
Claim 26: it is taught cells are cultured (e.g., Figure 9 legend), which absent reason to believe otherwise, is a sample dish.
Claim 27: Figure 9 legend teaches laser scanning.
Claim 28: as mentioned above, the pyramids represent patterned features.
Claim 29: due to the second law of thermodynamics, heat is always generated.
Claim 30: Images of the cells are provided (e.g., Figure 9).
Claim 31: the film contains the pyramids, which are laser-activated surfaces.
Claim 32: the cells are necessarily at a distance from the laser-activated surfaces, as they do not co-exist in the same space.
Claim 33: the substrate is coated with the film, and contains the active regions (pyramids).
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.
Claim(s) 1, 11-12, 14, 18-19, and 21-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Courvoisier, et al. (2015) “Plasmonic Tipless Pyramid Arrays for Cell Poration”, NanoLetters, 15: 4461-66, as applied to claims 1-5, 7, 9-15, 17, and 19-20, above, and further in view of Lee, et al. (2007) “Microfluidic System for Automated Cell-Based Assays”, JALA, 12(6): 363-67.
As shown above, the various claims are anticipated by Courvoisier alone, and thus, is also obvious over the same. However, the aspect of channels for delivery of media and removal of old media, is not taught.
On the other hand, this is well known in the art. In fact, Lee teaches the same in another advanced system for delivery and removal of media (e.g., Section “96-Well Plate Interface” on page 364). Such is taught for delivery and removal of media.
Thus, at the time of invention, it would have been obvious to modify Courvoisier to utilize an inlet and outlet for flow of media through the culture chamber. The Artisan would do so to feed the cells, and would expect success, as it has been known in the art for such use for years.
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.
Claim(s) 1, 11-12, 14, 19, and 21-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Courvoisier, et al. (2015) “Plasmonic Tipless Pyramid Arrays for Cell Poration”, NanoLetters, 15: 4461-66, as applied to claims 1-5, 7, 9-15, 17, and 19-20, above, and further in view of Woodruff & Maerkl (2016) “A High-Throughput Microfluidic Platform for Mammalian Cell Transfection and Culturing”, Scientific Reports, 6: 23937, 12 pages long.
As shown above, the various claims are anticipated by Courvoisier alone, and thus, is also obvious over the same. However, the aspect of moving cells into and out of the active region through a fluid channel is not specifically taught.
On the other hand, the Artisan, interested in transfecting cells, would be aware of Woodruff for teaching the use of channels to transfect cells in high throughput applications (e.g., Figure 1).
Thus, the Artisan would be motivated to apply Courvoisier’s method and modify it with Woodruff, to obtain a high throughput method of transfecting cells. The Artisan would also expect success, as the components are utilized for art-recognized purposes.
Conclusion
No claim is allowed.
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 ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
Prosecution Insights