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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1, 3, 5-6, 8, 11-12, 14-16, 18-19, drawn to a method of improving transfection efficiency, in the reply filed on 09/04/2025 is acknowledged.
Claims 20, 22, 24, 28-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Claims 1, 3, 5-6, 8, 11-12, 14-16, 18-20, 22, 24, 28-29 is/are currently pending with claims 20, 22, 24, 28-29 withdrawn.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.
Drawings
The drawings are objected to because Fig. 3 “electronic chips 104” are described on page 29 of the specification as indicating “six electronic chips”, but in Fig. 3, only five squares are indicated as “104”. While “104” in Fig. 3 only explicitly indicates five squares as electronic chips with lines connecting the squares with the labels “104”, the drawing shows six identical squares with one unmarked, and the unmarked square is interpreted to be the sixth “electronic chip”. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Figure 2 shows reference numbers “18” and “20”; Figure 9b shows reference “316”; Figure 11 shows reference number “24”; Figure 12b shows reference number “37”. These apparatus drawings are described on pages 25-32 and 49-53. Reference numbers “18” and “20” are not described in the description of Figs. 1-3 pages 25-32, and reference numbers “316”, “24”, and “37” are not described in the descriptions of Figs. 9a-12b pages 49-53.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference number “337” is described on page 52 of the specification, but is not shown in the provided drawings. 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. 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 Objections
Claims 1, 3, 5-6, 8, 11-12, 14-16, 18-19 are objected to because of the following informalities.
In claim 1, “any or any combination of…” in line 10 can be phrased in a clearer fashion. The examiner suggests: “any one of or any combination of the following:…”. This phrasing is also found in the following claims, and also must be corrected in the following claims: claim 5, lines 2-3; claim 8, line 2; claim 18, line 2; claim 19 lines 2-3.
Claim 1 recites a list of alternative limitations wherein multiple of the alternative limitations are not phrased in a grammatically-correct fashion. Each alternative limitation should be phrased such that they mirror one another syntactically (in this case, each alternative limitations should not be introduced with the word “at”, as “at” immediately precedes the phrase “any or any combination of” and thus modifies each of the subsequent alternative limitations).
Claims 3, 6, 8, 11-12, 14-16, 18-19 should be amended to add a comma after the preamble (for example, the preamble of claim 3 should read: “The method according to claim 1, wherein…”).
Claim 6 recites a list of alternative limitations wherein multiple of the alternative limitations are not phrased in a grammatically-correct fashion. Each alternative limitation should be phrased such that they mirror one another syntactically (in this case, each alternative limitation should be introduced with a verb, not the pronoun “it”, as the subject of the sentence should not be repeated). For grammatical correctness, claim 6 should read as follows:
“The method according to claim 1, wherein the agent associated with the at least one amphiphilic construct is contained within the amphiphilic construct, forms a complex with the amphiphilic construct, is contained on the amphiphilic construct, or is bonded to the amphiphilic construct.”
Claim 11 recites the limitations “is nucleic acid” in lines 2 and 3 and the limitation “testing expression level” in line 5. “is nucleic acid” must be corrected to read “is a nucleic acid”, as the article “a” is necessary for grammatical correctness. “testing expression level” must be corrected to read “testing expression levels” or “testing the expression levels”, as phrases such as “one or more” are conventionally considered to be grammatically “plural”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means”, wherein the term “means” is modified by functional language, and wherein the term “means” is not modified by sufficient structure, material, or acts for performing the claimed function. These claim limitations are as follows:
Claims 14-16, 18: “transmission means…for generating and/or transmitting the pulsed electromagnetic signals”, “transmission means”;
Claim 18: “control means for controlling operation”;
Claim 18: “power supply means for supplying electrical power”;
Claim 18: “memory means for storing data thereon”;
Claim 18: “user selection means for allowing a user to select the operation”;
Claim 18: “display means for displaying one or more settings”.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f), they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof, when present.
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.
Claim 1 recites the limitation “the method includes the step of directing pulsed electromagnetic signals provided at any or any combination of a pre-determined frequency, at a pre-determined pulse rate, or at a pre-determined power, at the transfection mixture at step a) prior to creating the transfection complex, at the transfection complex in step b), at the transfection complex in step c) and/or at the transfected cell complex after step c).” The phrasing of this list of alternative limitations, including the grammatical inconsistencies regarding the use of “at”, positions a pre-determined frequency, a pre-determined pulse rate, a pre-determined power, a transfection mixture, and a transfection complex as alternatives of each other. It is not clear how a transfection mixture or a transfection complex can be defined as a measure of electromagnetic signals. As a result, the metes and bounds of claim 1 are unclear, rendering claim 1 indefinite. Claims 3, 5-6, 8, 11-12, 14-16, and 18-19 depend on claim 1, but do not clarify the indefiniteness of claim 1, and as such, claims 3, 5-6, 8, 11-12, 14-16, and 18-19 are rendered indefinite.
Furthermore, regarding the above limitation of claim 1 which renders claim 1 indefinite, the phrasing “the transfection mixture at step a)” is unclear, and is interpreted to mean “the transfection mixture of step a)” or “the transfection mixture in step a)”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “nucleic acid”, and the claim also recites “DNA”, “RNA”, “a combination of DNA and RNA, mRNA, tRNA, siRNA or miRNA”, which are the narrower statement of the range/limitation. The genus of “nucleic acid” is presented as an alternative of “DNA”, “RNA”, and “a combination of DNA and RNA, mRNA, tRNA, siRNA or miRNA”, wherein these narrower limitations are species of “nucleic acids”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 11 depends on claim 5 but does not clarify this indefiniteness, and so claim 11 is rendered indefinite.
The term “approximately” in claims 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 11 and 18-19 depend on claims 5 and 14 and do not clarify this indefiniteness, and so claims 11 and 18-19 are rendered indefinite.
Claim 6 recites the limitation that “the agent…is contained on the amphiphilic construct”. “Contain” is defined as “to hold or include within”. It is thus unclear how an object can be contained on another object. Furthermore, the claim also recites the phrase “contained within” as an alternative, consistent with the known definition of the verb “contain” and which contrasts with the phrase “contained on”. It thus is interpreted that “contained within” and “contained on” should have different interpretations; however, based on the known definition of the verb “contain”, “contained on” could only mean “contained within”. As the meaning of this limitation is unclear, claim 6 is rendered indefinite.
Claim 12 recites the limitations “is approximately 15 minutes when the pulsed electromagnetic signals are directed at the transfection reagent” and “is approximately 1-4 hours when the pulsed electromagnetic signals are directed at the transfection mixture during or after transfection.” It is not clear what limitation “is approximately 15 minutes” or “is approximately 1-4 hours”, as “is approximately 15 minutes” and “is approximately 1-4 hours”, based on the phrasing of the claim, modify the term “the step of directing pulsed electromagnetic signals”, and a “step” cannot be a period of time. Furthermore, “when the pulsed electromagnetic signals are directed at the transfection reagent” and “when the pulsed electromagnetic signals are directed at the transfection mixture during or after transfection” do not make grammatical sense, as these phrases appear to directly modify “is approximately 15 minutes” and “is approximately 1-4 hours”, respectively. Because of the lack of clarity in the phrasing of claim 12, claim 12 is rendered indefinite. For the purposes of further examination, the examiner has interpreted claim 12 as follows:
“The method according to claim 1, wherein the step of directing pulsed electromagnetic signals:
(i) takes place over a predetermined period of time;
(ii) takes place over 15 minutes when the pulsed electromagnetic signals are directed at the transfection reagent; or
(iii) takes place over 1-4 hours when the pulsed electromagnetic signals are directed at the transfection mixture during or after transfection.”
Claim 14 recites the limitation “said plate is positioned…relative to said electronic device in use”. It is not clear what positional or spatial relationship is described by “positioned…relative to”, as this phrasing requires a term which describes the relative positioning (such as “on”, “in”, “above”, “in a different building”). It is not possible, based on this phrasing, to determine the metes and bounds of the spatial relationship between “said plate” and “said electronic device”. As such, claim 14 is rendered indefinite. Claims 15 and 18-19 depend on claim 14 but do not clarify this indefiniteness, and as such, claims 15 and 18-19 are rendered indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 15 recites the broad recitation “25cm or less”, and the claim also recites “20cm or less”, “15cmm or less”, “10cm or less”, “5cm or less”, and “1cm or less”, which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “approximately 2.2-2.6GHz”, and the claim also recites “2.4GHz +/- 50MHz” (2.35-2.45GHz; lines 3 and 4), “2.45 GHz +/-50MHz” (2.4-2.5GHz; line 4), which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation approximately 50Hz or less”, and the claim also recites “approximately 15Hz or less” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “approximately 1ms-20ms”, and the claim also recites “approximately 1ms” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “+2dBm to +4dBm” (1.5849mW-2.5119mW), and the claim also recites “2mW” and “w.5119mW”, which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim limitation “transmission means” in claims 14-16 and 18 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Page 11 of the specification describes “the transmission means” as preferably including “one or more transmission chips”. However, claim 14 presents “transmission means” and “one or more electronic transmission chips” as alternatives, indicating that the two limitations are different in some fashion. No other structure of a “transmission means” is described, and thus it is unclear what structure is implied by “transmission means” and is not “one or more electronic transmission chips”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claim 19 depends on claim 18 but does not clarify this indefiniteness, and so claim 19 is rendered indefinite.
Claim limitation “control means for controlling operation” in claim 18 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification describes the “control means” as having the functions of allowing the user options to select certain parameters (pages 18-19) and controlling operation of the device or “transmission means”; however, these functions are implied by the functional description in the claim “for controlling operation”, and do not imply any particular structure, material, or activity. The specification also indicates that the “control means” is depicted in the drawings as a “control unit”. However, the “control unit” in the drawings does not indicate any particular structure, material, or activity, as the drawings merely indicate the positioning of the “control means” relative to the device. The specification thus does not provide any particular structure or material to describe a “control means”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claim 19 depends on claim 18 but does not clarify this indefiniteness, and so claim 19 is rendered indefinite.
Claim limitation “user selection means for allowing a user to select the operation” in claim 18 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The only descriptions of the “user selection means” in the specification are found on page 18—wherein these “means” are defined by the function of allowing “user selection of one or more conditions, operation and/or one or more parameters of the device”, amounting to no more than the functional description in claim 18—and page 51—wherein the “selection means” are indicated to be “305” in Fig. 9a, wherein “305” in Fig. 9a merely indicates the positioning of the “selection means” relative to the device, and does not indicate the structure, material, or activity of the “selection means”. Thus, the specification does not provide a description of the structure or materials of the “selection means” of claim 18. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claim 19 depends on claim 18 but does not clarify this indefiniteness, and so claim 19 is rendered indefinite.
Claim limitation “display means” of claim 18 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The only description of “display means” in the specification is found on page 18, where “display means” are defined by the function of able to “display one or more settings, options for selection and/or the like.” This functional description does not provide any structural or material description of the “display means” of claim 18. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claim 19 depends on claim 18 but does not clarify this indefiniteness, and so claim 19 is rendered indefinite.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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”).
Claims 1 and 5 recite agents and amphiphilic constructs “suitable for transfection”, but the claims do not describe any chemical, structural, or functional characteristics that render an “agent” or “amphiphilic construct” “suitable for transfection”; as such, it would be unclear to artisan what “agents” or “amphiphilic constructs” are or are not “suitable for transfection”. This language in the claims creates massive genera encompassing all compositions which can be considered an “agent” or an “amphiphilic construct”. The disclosure does not provide a description of structural, chemical, or functional characteristics which would render an “agent” or “amphiphilic construct” “suitable for transfection”. As such, the phrase “suitable for transfection” is not sufficiently described in the disclosure such that an artisan would understand the structural, chemical, or functional characteristics implied by the phrase or such that an artisan could determine that the applicants were in possession of the full scope of “agents” and “amphiphilic constructs” which can be considered “suitable for transfection”.
Moreover, the terms “agent” and “amphiphilic construct” are not sufficiently described by the disclosure. On page 7 of the specification, an “agent” comprises, in some embodiments, “a nucleic acid”, and in other embodiments, the agent “does not comprise a nucleic acid”. On page 17, an “agent” is described as comprising, in some embodiments, “nucleic acids, peptides, small molecules and other agents”. The dictionary definition of “agent” encompasses “a substance that causes a reaction”, “a drug or chemical capable of eliciting a biological response”, and “any microorganism capable of causing disease” (see Dictionary.com “Agent” definitions 11-13, provided herein). The known definitions of the term “agent” encompass but are not limited to the specific types of agents disclosed (nucleic acids, peptides, small molecules). An artisan would not be able to determine that the applicants were in possession of the full scope of the genus of “agents”, as understood based on the common definitions of the term “agent” and on the absence of a different or more narrow definition of “agent” in the disclosure.
While the genus of compounds described as “amphiphilic constructs” is broad, the disclosure only describes a small number of species of “amphiphilic constructs” which are not representative of the full genus. On page 31, the specification describes that “amphiphilic constructs” used by the applicants are “Turbofect™”, PEI, and “TransIT®-2020”. However, an artisan would recognize that the genus of “amphiphilic constructs” encompasses all molecules with hydrophobic and hydrophilic components, including detergents, soaps, and phospholipids (see ScienceDirect “Amphiphilic Molecule” general overview, provided herein). The three species of amphiphilic constructs described in the present specification are not representative of the full scope of the genus of “amphiphilic constructs”, and thus, an artisan would not be able to determine that the applicants were in possession of the full scope of the genus of “amphiphilic constructs”.
Claim 5 further 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.
Claims 3, 6, 8, 11-12, 14-16, and 18-19 depend on claims 1 and 5 but do not sufficiently further describe the genera of “agents”, “amphiphilic constructs”, agents or amphiphilic constructs “suitable for transfection”, “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.
Claims 14-16 and 18 recite limitations that use the word “means”, wherein the term “means” is modified by functional language, and wherein the term “means” is not modified by sufficient structure, material, or acts for performing the claimed function, and which must be interpreted under 35 USC 112(f), as described under “Claim Interpretation”.
The specification does not provide structural descriptions of species of “control means”, “selection means”, or “display means”, and the functional descriptions cannot be considered to be identifying characteristics of a representative number of species of each limitation as every species would have the described function (“control means for controlling operation”, “user selection means for allowing a user to select the operation”, “display means for displaying one or more settings”); as such, an artisan would not be able to determine what structural or functional characteristics could or could not be encompassed by these limitations, nor whether the applicants were in possession of the full scope of the genera of “control means”, “selection means”, or “display means”.
While some species of “transmission means”, “memory means”, and “power supply means” are described in the disclosure, these are not representative of the full scope of the genera of “transmission means”, “memory means”, or “power supply means”. “Transmission means” are described as preferably including “one or more transmission chips”; however, “transmission chips” are not the only structures or materials which are capable of transmitting or generating pulsed electromagnetic signals. Other structures, such as wire coils, which are capable of producing electromagnetic signals, are not described in the disclosure. As such, the full scope of the genus of “transmission means” is not described. On page 18 of the specification, “power supply means” are described as including “a mains electrical power supply, one or more batteries, power cells, one or more rechargeable batteries, electrical generator means and/or the like”. However, this does not describe representative examples of all types of “power supply means for supplying electrical power” and does not limit “power supply means” to these embodiments (these are preferably what a power supply means includes). Any structure which is capable of storing or providing power is encompassed, including but not limited to a solar panel or a hand crank, but what is described is very narrow in comparison. As such, the disclosure fails to describe species representative of the full scope of the genus of “power supply means”. On page 18 of the specification, “memory means” are described, in a non-limiting fashion, as a “memory device, data storage device and/or the like” (this is considered non-limiting because of the use of “such as”, “and the like”, which broaden the scope of the description to include all species which are not described). An artisan would recognize that “memory means for storing data thereon” encompass all structures which provide the function of storing data, including a notepad on which data can be written. However, the species described in the present disclosure are not representative of the full scope of the genus of “memory means”. For these reasons, the limitations “transmission means”, “control means”, “power supply means”, “memory means”, “selection means”, and “display means” are not sufficiently described by the present disclosure.
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 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.
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.
(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.
Claim(s) 1, 3, 5-6, 8, 11-12, 14-16, 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dahmani (2013; provided by Applicant with IDS filed 10/06/2022).
Regarding claim 1, Dahmani teaches a method of enhancing transfection efficiency eukaryotic cells (abstract; page 166, “3.1. Enhanced transfection of adherent cells induced by magnetic pulses”), comprising the following steps:
providing a transfection mixture including an agent associated with an amphiphilic construct suitable for transfection (the amphiphilic construct PEI, agents DF-Gold, Mag2);
introducing the transfection mixture to one or more eukaryotic cells to form a transfection complex (introduced to Jurkat T cells or H441 cells);
allowing the transfection complex to undergo a transfection process to form one or more transfected cells (see page 164-165 for steps (a)-(c)).
Dahmani teaches that the method includes the step of directing pulsed electromagnetic signals having a pre-determined frequency, pre-determined amplitude, and pre-determined exposure time (abstract; pages 165-166). Dahmani teaches that the pulsed electromagnetic signals were provided before the formation of the transfection complex of step (b), during step (c), and after step (c) (page 165).
Regarding claim 3, Dahmani teaches that the cells are suspended or adherent (page 164), that the cells are immortal cells (page 164), that the cells have been derived from human tissue (page 164), and that the cells are T cells (page 164) (Dahmani teaches the cells are NCI-H441 human pulmonary epithelial cells derived from human tissue or Jurkat T cells).
Regarding claim 5, Dahmani teaches that the agents of step (a) are used in a transfection method (pages 164-166: DF-Gold, Mag2) and thus are considered “suitable for transfection”. Dahmani teaches that the transfection mixture additionally comprises plasmid DNA (page 164) (recited in claim 5 as being an “agent”). The plasmid DNA is considered to be encompassed by the claim limitations “small molecule” or “large molecule”, as it must have a non-zero mass less than, equal to, or greater than 5 kDa, and is encompassed by the claim limitation “one or more expression vectors”, as a plasmid is an expression vector.
Regarding claim 6, Dahmani teaches that the agents (plasmid DNA, DF-Gold, Mag2) are associated with the at least one amphiphilic construct (PEI) by forming a complex with the amphiphilic construct (PEI-Mag2-DF-Gold) or by being contained within the complex formed by the amphiphilic construct (the plasmid DNA is encapsulated by the lipoplex formed by the PEI-Mag2-DF-Gold complex) (page 164).
Regarding claim 8, Dahmani teaches that the amphiphilic construct comprises PEI (page 164).
Regarding claim 11, Dahmani teaches that the agent is a nucleic acid (plasmid DNA, page 164). Dahmani teaches that the method results in transfected cells, but does not teach additional steps for the production of stably-transfected cells (a selection step would be required for this), and as such, Dahmani teaches that the method produces transiently-transfected cells (Fig. 5; page 166). As Dahmani does not teach a method for stably transfecting cells, Dahmani is not required to teach the method steps of “isolating one or more of the eukaryotic cells after the transfection process, testing expression level of one or more peptides encoded by the agent in the one or more isolated eukaryotic cells or progeny thereof, and selecting one or more isolated eukaryotic cells or progeny based upon the expr