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 .
DETAILED ACTION
Claim status
Claims 1-2, 5, 7, 10-11, 13, 15-16, 18-20, 22, 24, 28, and 29 are pending
Claims 10, 20, 22, 24, 28, and 29 are withdrawn
Claims 1-2, 5, 7, 11, 13, 15-16, 18-19 are under examination
Election/Restrictions
Applicant’s election of the following invention without traverse in the reply filed on 8/21/2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 1-2, 5, 7, 10-11, 13, 15-16, 18-19, drawn to a method for providing improved transection efficiency and/or intracellular delivery in eukaryotic cells.
Claims 20, 22, 24, 28, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable linking claim.
Applicant’s election of the following species is acknowledged.
Applicant elects pharmaceutical agents as the naked agent.
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/20/2022 and 10/06/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 2 is objected to because of the following informalities: the phrase “and/or any or any combination of” is repetitive statement and unnecessarily verbose. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-2, 5, 7, 11, 13, 15-16, 18-19 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 pre-AIA the applicant regards as the invention.
In regard to Claim 1, instant claim recites the broad recitation of “transduction and/or intra-cellular delivery” in the preamble and step (a), and the claim also recites “transduction or intra-cellular delivery” in step (c) which is the narrower statement of the limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c ). Dependent claims 2, 5, 7, 11, 13, 15-16, 18-19 are included in the basis of this rejection because they do not clarify scope of step (c).
Claim 13 recites three (3) limitations directed to the electronic device “in use”. However, although structural features of the device are claimed, instant claim 13 recites no active steps in the claimed uses of the device. MPEP 2173.05 states that attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b). For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parteErlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Claim 15 recites the phrase "the distance between the transmission means” in regard to the method of Claim 1. There is insufficient antecedent basis for this limitation in the claim because Claim 1 is not directed to a transmission means, thereby rendering Claim 15 indefinite.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, Claim 2 recites the limitation directed to the at least one naked agent of claim 1 that “is any agent suitable for transfection and/or intra-cellular delivery and/or any or any combination of” a Markush group of agents, which does NOT narrow the scope of claim 1 where the at least one naked agent of claim 1 that is any agent “suitable for transfection and/or intra-cellular delivery”. Essentially, due to the Applicant’s alternative claim language, the first embodiment of claim 2 does not narrow the scope of claim 1. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5, 7, 11, 13, 15-16, 18-19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ostrow et al. (US2002/0147424, filed 12/26/2001, published 10/10/2002)
Ostrow et al. teaches a method for providing improved intracellular delivery in eukaryotic skin cells comprising transdermal magnetic delivery comprising:
Providing at least one substance suitable for intra-cellular delivery,
Introducing the substance to eukaryotic skin to form a mixture,
Allowing the mixture to undergo intra-cellular delivery to form treated skin cells, wherein the method includes the step of directing pulsed electromagnetic signals at a predetermined pulse rate at the mixture during step c) [0032, 0088, 0116, 0171], see Figs. 3, 5 & 9, see also Claim 27 of Ostrow).
In regard to the substance being “naked” as per claims 1 and 2, Ostrow teaches the substance is pharmaceutical compound ([0124, 0139, 0143], see also Claim 29 of Ostrow). Applicant’s specification defines “naked” as not being associated with an amphiphilic construct such as a cationic polymer, PEI, or polyamines, which the disclosure of Ostrow makes clear is unnecessary to the transdermal magnetic drug delivery method.
In regard to claim 5, as stated supra, Ostrow teaches the cells are skin, which is derived from the tissue of an animal.
In regard to claim 7, Ostrow teaches the method includes the step of mixing the agent with a carrier ([0139, 0143, 0179], Fig. 5, #38, see Claim 28 of Ostrow).
In regard to claim 11, Ostrow teaches the method includes directing the pulsed electromagnetic signals for a pre-determined period of time ([0171], see Fig. 9).
In regard to claim 13, Ostrow teaches the pulsed electromagnetic signals are generated by an electronic device, and wherein the electronic device comprises a plurality of transmission means for transmitting the electromagnetic signals ([0141, 0165], see Figs 5-7).
In regard to claim 15, Ostrow teaches the skin is placed in contact with the transmission means (i.e., 1 cm or less) [0142], see Fig. 5, skin is #34).
In regard to claim 16, Ostrow teaches the pre-determined pulse rate is approximates 2 pulses every 10 seconds (i.e., about 0.2 Hz, which is less than 15Hz) (see Fig. 9).
In regard to claim 18-19, Ostrow teaches the electronic device comprises a pulse generator ([0146-0147, 0154-0158], Fig. 5, #52), which controls the waveform as demonstrated by the adjustments in the directionality and rest periods between pulses [0136].
Accordingly, Ostrow anticipates instant claims.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631