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 response filed 04/14/2026 has been received and considered entered. This is a response to amendments and arguments filed 04/14/2026.
Election/Restrictions
Claims 20, 22, 24, 28-29 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/04/2025.
Claims Status
Claims 2, 4, 7, 9-10, 13, 17, 21, 23, 25-27, 30-31 is/are cancelled. Claims 1, 3, 5-6, 8, 11-12, 14-16, 18-20, 22, 24, 28-29 is/are currently pending with claims 20, 22, 24, 28-29 withdrawn. Claims 1, 3, 5-6, 8, 11-12, 14-16, 18-19 is/are under examination.
Information Disclosure Statement
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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Hyperlinks were found on pages 35 and 43. Applicant is advised to review the specification in order to ensure that all hyperlinks are identified and appropriately removed. The amendments to the specification did not remove prefixes such as http:// or other browser-executable code.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 recites in lines 2-3 “the pre-determined frequency of the pulsed electromagnetic signals is between approximately 2.4GHz +/- 50MHz”. For grammatical correctness, this should read “the pre-determined frequency of the pulsed electromagnetic signals is approximately 2.4GHz +/- 50MHz”. This is a new objection.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 3, 5-6, 8, 11-12, 14-16, and 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This rejection is maintained and modified in response to the amendment to claim 1.
The term “approximately” in claims 1, 5, 12, 14-16 is a relative term which renders the claim indefinite. The term “approximately” 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 “approximately” modifies a numerical limitation by introducing a range of acceptable “error”. The specification does not define the acceptable “error” implied by the term “approximately”, and as such, a numerical value modified by the term “approximately” can have an infinite range of acceptable error. As a result, the metes and bounds of any limitation modified by the term “approximately” are not clear, and claims 5, 12, and 14-16 are rendered indefinite. Claims 3, 6, 8, 11, 18-19 depend on claim 1 and do not clarify this indefiniteness, and so claims 3, 6, 8, 11, 18-19 are rendered indefinite.
112(a):
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.
Written Description:
Claims 1, 3, 5-6, 8, 11-12, 14-16, and 18-19 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it”).
Claim 5 recites “a pharmaceutical and/or therapeutic agent or compound, an agent of therapeutic and/or pharmaceutical interest, a small molecule or small molecular material of less than 5 Kilodaltons, a large molecule or large molecular material of greater than or equal to approximately 5 Kilodaltons, one or more proteins, vaccine, an organic agent, one or more antibodies”. “Pharmaceutical and/or therapeutic agents or compounds” and “agents of therapeutic and/or pharmaceutical interest” are only described by the functional characteristic of having “been developed for use and/or being investigated for use in research and/or in the clinic” (page 6). This functional description cannot be an identifying characteristic for the claimed diverse genus of “pharmaceutical and/or therapeutic agents or compounds” or “agents of therapeutic and/or pharmaceutical interest” because all members of the claimed genus will have that characteristic. No structural description is provided for this genus of molecules. The disclosure likewise does not provide structural descriptions of the genera of “small molecules”, “large molecules”, “proteins”, “vaccines”, “organic agents”, or “antibodies”, nor does the description provide any other identifying characteristics that would sufficiently describe a representative number of species of these genera. The recitation of “small molecules” and “large molecules” as alternatives encompasses every molecule that exists, as all molecules can be classified as less than 5 kD or greater than or equal to 5kD; the disclosure does not provide a representative number of species of all molecules that exist. The genus of “organic agents” is considered to encompass all organic molecules, as neither the claims nor disclosure limit the definition of the term “organic agent”; however, the disclosure does not describe a representative number of species of “organic molecules” such that the entire genus of “organic molecules” is described, by structural, functional, or other relevant identifying characteristics. The genera of “proteins”, “vaccines”, and “antibodies” are huge genera encompassing large numbers of molecules with distinct structures; however, the disclosure does not provide descriptions of complete structures of a representative number of species of these genera, nor does not the disclosure provide descriptions of other relevant identifying characteristics which could describe a representative number of species of these genera. As such, the recitation of “proteins”, “vaccines”, and “antibodies” encompasses all proteins, vaccines, and antibodies that exist, without sufficient written description such that an artisan could determine that the applicants were in possession of the full scope of these genera.
Claim 1 and its dependent claims 3, 6, 8, 12, 14-16, and 18-19 broadly encompass the limitations of claim 5, and thus also lack sufficient written description. Claim 11 depends on claim 5 but does not sufficiently further describe the genera of “pharmaceutical and/or therapeutic agents or compounds”, “agents of therapeutic and/or pharmaceutical interest”, “small molecules”, “large molecules”, “proteins”, “vaccines”, “organic agents”, or “antibodies” such that an artisan could determine that the applicants were in possession of the full scope of these genera.
According to the MPEP § 2163, "The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutsch land GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.")."
Claims 1, 3, 5-6, 8, 11-12, 14-16, and 18-19, as described above, recite or encompass claim limitations which encompass broad genera of species, of which no species or a limited, non-representative number of species are described in the disclosure. The disclosure does not provide sufficient structural or otherwise identifying characteristics of representative numbers of species of these genera, and the functional limitations provided regarding some of these genera fail to sufficiently further describe or limit these genera. As a result of the lack of written description described in the arguments above, claims 1, 3, 5-6, 8, 11-12, 14-16, and 18-19 are rejected for failing to comply with the written description requirement.
Response to Arguments
Applicant's arguments filed 04/14/2026 have been fully considered but they are not persuasive.
Regarding the above maintained rejection over 35 USC 112(b):
Applicant argues that the relative term “approximately” accounts “for normal manufacturing tolerances and measurement variations” and that a person of ordinary skill in the art would understand it as such, based on the specification. However, Applicant does not indicate any teaching in the specification or the art which provides an acceptable range of measurement variations, manufacturing tolerances, or error which the relative term “approximately” implies. An artisan would not be able to assume without any teaching in the disclosure or art what degree of variation (for example, percent variance) would be or would not be encompassed by the term “approximately”. As such, this rejection is maintained.
Regarding the above maintained rejection over 35 USC 112(a):
Applicant addressed the terms “agents/amphiphilic construct suitable for transfection”, but did not address or amend the genera of “pharmaceutical and/or therapeutic agents or compounds”, “agents of therapeutic and/or pharmaceutical interest”, “small molecules”, “large molecules”, “proteins”, “vaccines”, “organic agents”, or “antibodies” such that an artisan could determine that the applicants were in possession of the full scope of these genera. As such, this rejection is maintained.
Withdrawn Rejections - 35 USC § 102
The rejection of claims under 35 USC 102 was withdrawn because Applicant correctly identified that Dahmani teaches pulsed magnetic signals, and not electromagnetic signals. A further search of the art did not yield art teaching a method of improving transfection efficiency in eukaryotic cells, the method comprising a step of directing pulsed electromagnetic signals having a pre-determined frequency of any frequency to a mixture of transfection reagents, or to a mixture of eukaryotic cells and transfection reagents.
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, 3, 5-6, 8, 11-12, 14-16, 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7, 10-11, 13, 15-16, 18-19 of copending Application No. 17912932 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following. The only difference between the instant claim limitations and the copending claim limitations is that the copending claims recite a “naked agent” (see copending claim 1), whereas the instant claims recite “an agent associated with at least one amphiphilic construct” (see claim 1). Copending claim 7, however, provides the further limitation that the at least one agent is mixed with “one or more carrier agents and/or solubilizing agents”. On page 4 of the copending specification, “carrier molecule” is described as encompassing a “liposomal carrier”. On page 8 of the copending specification, “naked agent” is defined as preferably describing an “agent that is not associated with an amphiphilic construct”, but that “in some transfection protocols, a nucleic acid molecule is generally associated with a carrier or construct which may be an amphiphilic construct” (emphasis added). On page 10 of the copending specification, “the one or more other carrier agents or solubilising agents” are described as including, but not being limited to, “water, buffer solution, Tris-EDTA, phosphate buffered saline (PBS), ethanol, apolar or aprotic agent and/or the like”. Based on the copending specification, it is interpreted that the “carrier molecule” of copending claim 7 is preferably (but not necessarily) not an amphiphilic construct; as this definition is non-limiting, the “carrier molecule” of copending claim 7 can be an amphiphilic construct, including a liposomal material. As such, the copending methods, in view of term definitions in the copending specification, recite all of the required limitations of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. 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 AFRICA M MCLEOD whose telephone number is (703)756-1907. The examiner can normally be reached Mon-Fri 9:00AM-6:00PM EST.
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, Ram Shukla can be reached on (571) 272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
For those applications where applicant wishes to communicate with the examiner via Internet communications, e.g., email or video conferencing tools, the following is a sample authorization form which may be used by applicant:
"Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file."
To facilitate processing of the internet communication authorization or withdraw of authorization, the Office strongly encourages use of Form PTO/SB/439, available at www.uspto.gov/patent/patents-forms. The form may be filed via EFS-Web using the document description Internet Communications Authorized or Internet Communications Authorization Withdrawn to facilitate processing. See MPEP 502.03(II).
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/AFRICA M MCLEOD/ Examiner, Art Unit 1635
/KIMBERLY CHONG/ Primary Examiner, Art Unit 1636
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