DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 common substrate comprises one or more cell carriers (claim 9), the wells forming a cavity with a continuous opening are substantially devoid of a floor (claim 13), the shared media reservoir extends below the opposed second surface of the common substrate (claim 14) 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.
Claims1-20 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.
Claims 1, 5, 10, 13 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 1 is vague and unclear reciting “wherein the apparatus is configured to allow the retrieval of single cells or cell colonies individually segregated in the wells of the common substrate” because it is unclear what structural configuration is being claimed. It is further unclear whether the limitations following the phrase “configured” are part of the claimed invention because the single cells or cell colonies are not positive elements of the claim.
Claim 5 is similarly unclear reciting “wherein the shared media reservoir is configured to receive and/or contain a liquid media, wherein the liquid media comprises one or more cells to be cultured, wherein application of the liquid media containing the one or more cells to the shared media reservoir causes the one or more cells to be cultured to come into contact with the common substrate” because it is unclear what structural configuration is being claimed, and whether the limitations following the phrase “configured” are part of the claimed invention.
Claim 10 is similarly unclear reciting “the carriers configured to release from the substrate upon mechanical distortion of the common substrate” because it is unclear what structural configuration is being claimed. In addition, “the carriers” is unclear if the recitation is referring to the each of the one or more cell carriers in L1 of the claim.
Claim 13 is unclear reciting “wherein the wells forming a cavity with a continuous opening are substantially devoid of a floor”. It is unclear if the applicant is claiming the wells form a cavity through (continuous) the entire structure of the common substrate.
For the reasons above, dependent claims relating to these limitations are also unclear.
Claim 1 recites the limitation "the wells" in L7/L15. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the biologically active material" in L1. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the carriers" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the carriers" in L3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the substrate" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the wells" in L2/L6. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the walls" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the wells" in L2/L6. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the walls" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the substrate" in L7. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the wells" in L1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the resilient polymeric material" in L1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the array" in L1. There is insufficient antecedent basis for this limitation in the claim. It is unclear which array is being referred.
Claim 18 recites the limitation "the array" in L1. There is insufficient antecedent basis for this limitation in the claim. It is unclear which array is being referred.
Claim 19 recites the limitation "the housing" in L1. There is insufficient antecedent basis for this limitation in the claim. It is unclear which array is being referred.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-10 & 12-20 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipate by Allbritton et al. (US 2007/0238122).
Regarding claim 1, Allbritton et al. teach:
1. An apparatus comprising:
a common substrate (e.g., micro-array plate 10),
the common substrate having a first surface (i.e., a pallet/post surface) and an opposed second surface (i.e., an electrode surface; see Fig. 4 for example),
the common substrate having a plurality of wells (i.e., micro-patterned features such as wells ¶ 0070) formed in the first surface in the form of an array (see Fig. 5 for example), the wells in the common substrate defined by side walls (i.e., bottom walls; see Figs. 1A, 3, 5 for example),
wherein the common substrate is capable of allowing cell growth on the first surface (¶ 0058+), and
a shared media reservoir (e.g., single well 47), wherein the shared media reservoir extends across the plurality of wells formed in the first surface of the common substrate in the form of an array (see Fig. 5 for example),
wherein the apparatus is capable of allowing the retrieval of single cells or cell colonies individually segregated in the wells of the common substrate (see ¶ 0055 & Fig. 7B for example).
With regard to limitations in claims 1, 5, 6, 7, 8, 10, 15 (e.g., to allow cell growth on the first surface, [...] to allow the retrieval of single cells or cell colonies individually segregated in the wells of the common substrate, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2-10, 12-20, Allbritton et al. teach:
2. The apparatus of claim 1, wherein the common substrate defines the shared media reservoir (see Fig. 5 for example).
3. The apparatus of claim 1, wherein the common substrate is formed from a flexible or elastomeric material (the term flexible is sufficiently broad to have read on the glass slides as taught in ¶ 0069; see also incorporated reference in ¶ 0069, U.S. patent application Ser. No. 11/539695 (Wang et al. US 2007/0128716) teach a plastic ¶ 0029).
4. The apparatus of claim 1, further comprising a housing (e.g., cassettes or trays) for supporting the common substrate (¶ 0008+).
5. The apparatus of claim 1, wherein the shared media reservoir is capable of receiving or containing a liquid media, wherein the liquid media comprises one or more cells to be cultured (¶ 0037+).
6. The apparatus of claim 1, wherein common substrate comprises a supporting surface or a layer capable of cell growth (see i.e., The plate can contain structures or chemical treatments that enhance or promote the attachment and/or function of the samples, and that promote or assist in their analyses. Abstract).
7. The apparatus of claim 1, wherein the common substrate is coated with a molecule on at least the first surface thereof (see i.e., The plate can contain structures or chemical treatments that enhance or promote the attachment and/or function of the samples, and that promote or assist in their analyses. Abstract; The top surfaces of pallets were then modified using collagen or fibronectin to enhance cell adhesion. ¶ 0069).
8. The apparatus of claim 1, wherein the material is selected from the group consisting of a peptide, a protein, a carbohydrate, a nucleic acid, a lipid, a polysaccharide, a hormone, an extracellular matrix molecule, a cell adhesion molecule, a natural polymer, an enzyme, an antibody, an antigen, a polynucleotide, a growth factor, a synthetic polymer, polylysine, a drug, and any combination thereof (see i.e., The plate can contain structures or chemical treatments that enhance or promote the attachment and/or function of the samples, and that promote or assist in their analyses. Abstract; The top surfaces of pallets were then modified using collagen or fibronectin to enhance cell adhesion. ¶ 0069).
9. The apparatus of claim 1, wherein the common substrate comprises one or more cell carriers (e.g., pallets), wherein the cell carriers are transparent or semitransparent (¶ 0049-0050).
10. The apparatus of claim 9, wherein each of the one or more cell carriers is disposed in one of the wells such that each cell carrier engages the side walls of the well (see Figs. 1A, 3, 5 for example) and is resiliently held in the one of the wells, the carriers capable of being released from the substrate (see i.e., Pallets 72a containing the cells of interest are (sample 74) dislodged (released), at step 6, from the plate, preferably, e.g., by a high energy laser pulse 77 from a laser 78. ¶ 0055).
12. The apparatus of claim 1 wherein: the wells in the common substrate are separated by walls, the walls have an average width of at least 2 micrometers, up to 1000 micrometers (¶ 0070, 0074); and the walls have an average height of at least 2 micrometers, up to 1000 micrometers (¶ 0070, 0074); the wells forming a cavity in the common substrate with a continuous opening from first surface of the substrate to the second opposed surface of the substrate (see Fig. 4 for example).
13. The apparatus of claim 12, wherein the wells forming a cavity with a continuous opening (see Figs. 1A, 3, 5 for example).
14. The apparatus of claim 12, wherein the shared media reservoir extends below the opposed second surface of the common substrate (see Fig. 4 for example).
15. The apparatus of claim 1, wherein the common substrate is formed from a polymeric material (¶ 0069).
16. The apparatus of claim 15, wherein the polymeric material is selected from the group consisting of silicones, polyurethane, styrene-butadiene copolymer, polyolefin and polydiene elastomers, thermoplastic elastomers or combinations thereof (¶ 0069).
17. The apparatus of claim 1, wherein the array is uniform or non-uniform (¶ 0045).
18. The apparatus of claim 1, wherein the array is arranged in an interdigitated pattern (see Fig. 9 for example).
19. The apparatus of claim 1, wherein a housing comprises a cassette formed from poly carbonate or glass (¶ 0060).
20. The apparatus of claim 19, wherein the cassette includes a scaffold (e.g., fluidic cap, see Figs. 6, 9-11 for example).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Allbritton et al. (US 2007/0238122) in view of Wang et al. (US 2007/0128716).
Regarding claim 11, Allbritton et al. teach: 11. The apparatus of claim 1 wherein: the wells in the common substrate are separated by walls, the walls have an average width of at least 2 micrometers, up to 1000 micrometers (¶ 0070, 0074); and the walls have an average height of at least 2 micrometers, up to 1000 micrometers (¶ 0070, 0074); the wells in the common substrate have floors (see Figs. 1A, 4, 5 for example). Although Allbritton et al. teach forming the common substrate to have the desired thickness (¶ 0069), the reference does not explicitly teach: the floors have an average thickness of from 2 to 500 micrometers.
However, Allbritton et al. incorporate a reference in ¶ 0069, U.S. patent application Ser. No. 11/539695 (Wang et al. US 2007/0128716) that teaches dimensions of from 2 to 500 micrometers (¶ 0028+).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the floor dimension of Allbritton et al. to have a dimension of 2 to 500 micrometers, as taught by Wang et al., since varying the floor dimension of the wells is merely a design choice that would be prima facie obvious to one of ordinary skill in the art according the use of the plate for patterning biological and non-biological materials (Allbritton et al. 0069; Wang et al. ¶ 0020, 0028-0037).
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.
Claims 1, 7, 9, 11, 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8 of U.S. Patent No. 9,963,666. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are a broader version of the ‘666 and are therefore fully encompassed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bachman et al. (U.S. application Ser. No. 11/243,926; US 2006/0121500), which is incorporated by Wang et al. (U.S. patent application Ser. No. 11/539695; US 2007/0128716), which is incorporated by Allbritton et al. (US 2007/0238122) teach: a patterned deposition method to form a patterned deposition on surfaces of removable pallets (Abstract, ¶ 0021-0027+)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798