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 .
New Examiner of Record
The new examiner of record is Erin Hirt.
Status of Application
The new examiner has reviewed the previous office action and claims, etc. This has prompted the new grounds of rejection in this third non-final office action which was reviewed by a supervisor, see SPE signature below.
Claim Objections
Claim 82 is objected to because of the following informalities: please define abbreviations in the first instance they are used e.g. CELiD, etc. as was done in all previous claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 9-18, 20-25, 31, 36, 43, 46-47, 51, 55-56, 63, 82-84, 86-87, and 102 and rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the ionizable lipids of claim 19, does not reasonably provide enablement for the ionizable lipids of formula (I) of claim 1 from which all of the above dependent claims depend either directly or indirectly. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Specifically, applicant’s claims for instance terminal groups on their formula (I) e.g. R6 and R6’ which are alkylene groups. However, alkylene groups are by definition divalent groups, e.g. CH2 groups and a CH2 divalent group cannot be a terminal group unless something else is bound to it because a divalent CH2 group which is only bound on one side and therefore lacks a required group to fill its octet and/or valence shell and as such the compounds are not enabled and/or cannot exist as they are instantly claimed as the valence shells/octets around the terminal atoms of R6 and R6’ are incomplete as claimed and as such the claimed compounds are not enabled.
Claims 2-7, 9-18, 20-25, 31, 36, 43, 46-47, 51, 55-56, 63, 82-84, 86-87, and 102 are also rejected because they depend from rejected claim 1.
Claim 84, 86-87, 102 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating various diseases which can be targeted/treated with various nucleic acids when administered to patients in need of such treatment cannot treat any and all diseases or disorders in subjects which do not need to have the disease as is claimed by claim 84. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Specifically, nucleic acids in lipid nanoparticles are not useful or effective for treating for instance prion diseases as prions do not contain nucleic acids so they cannot be targeted/treated with the claimed pharmaceutical composition comprising the claimed lipid nanoparticles comprising the claimed lipids and nucleic acids. Thus, the claimed method for treating any and all known and unknown diseases and disorders by administering to any subject whether or not they are in need of said treatment is not enabled as it is currently claimed. Additionally, diseases or disorders cannot be effectively treated if the subject to which the composition is administered is not in need of said treatment, e.g. does not have the disease or disorder applicants are trying to treat. Thus, again applicant’s method is not enabled for treating any and all diseases or disorders in any subject (including those which are not in need of said treatment and/or do not have said disease or disorder). Thus, for the above reasons applicants are not fully enabled for the method they claim in claim 84.
The claims which depend from rejected claim 84 are also rejected as they depend from rejected claim 84.
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 9-10, 13, 17, 22, 31, 36, 43, and 82 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 9-10 are indefinite because they recite that R2 or R2’ respectively are optionally substituted branched C1-6 alkylene. These claims depend from claim 1 which firstly does not allow for R2 or R2’ to be optionally substituted thus, this limitation lacks antecedent basis from claim 1 from which these claims depend. Secondly, claim 1 was amended to C1-3 alkylene groups and as such C1-6 also lacks antecedent basis from claim 1. Thus, it is unclear what scope of R2 or R2’ applicants are trying to encompass with this claim.
Claim 13 is rejected because it depends from claim 9 and does not resolve the above ambiguity.
Claim 17 is indefinite because it is not clear if m and n are still allowed to be independently selected as recited in claim 1, based on the plain language of claim 17 as written, or if claim 17 now requires m and n to each be 3 or each be 5 or if they can each independently be 3 or 5? Thus, the metes and bounds of what scope applicants are trying to claim with m and n are unclear at this time.
Claims 22 and 82 contain the trademark/trade name doggyboneTM DNA. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe enzymatically produced cell-free DNA that is in the form of a circular vector of double stranded DNA, accordingly, the identification/description is indefinite.
Claim 31 is indefinite because it recites the cholesterol. However, there is no cholesterol disclosed or required by claim 24 (from which claim 31 depends) which only recites a sterol. As such it is unclear where “the cholesterol” is coming from, and as such the claim lacks antecedent basis for this limitation.
Claims 36 and 43 are also rejected because they depend either directly or indirectly from claim 31 and do not resolve the above ambiguity.
Claim 82 contains the trademark/trade name MIDGETM which is trademarked by PlasmidFactory. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a DNA technology/a specific type of DNA formed from this technology, and accordingly, the identification/description is indefinite.
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.
Claims 9-10 are 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. Claims 9-10 recite R2 or R2’, respectively, are optionally substituted branched C1-6 alkylene. Claims 9-10 depend from claim 1 which has defined R2 and R2’ to be linear C1-C3 alkylene which is shorter in length than the chain length claimed in dependent claims 9-10, and claim 1 does not allow for optional substitution of the alkylene groups. Thus, claims 9-10 improperly broaden claim 1 from which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claim 19 is allowed.
Closest Prior Art
The closest prior art to applicant’s compounds is Asakawa cited by the previous examiner and then withdrawn by the previous examiner for not teaching the branched groups that are required by the instantly claimed compounds. Nothing in Asakawa would have directed one of ordinary skill in the art to make the claimed lipids without impermissible hindsight especially since the lipids instantly claimed are not always charged by the amine groups are ionizable under the right conditions where the lone pair of electrons on nitrogen would pick up a hydrogen, whereas the compounds in Asakawa are quaternary amine salts which carry a permanent charge. The examiner notes that applicant’s IDS also shows other close prior art but the compounds all contain for instance ester groups within the chain, etc. which are not allowed in the instantly claimed compounds as claimed nor do the compounds have the branched chain of the claimed lengths coming off of the nitrogen atoms (See for instance compounds in Tange US20140335157 or Nakai et al. US20180155304).
Response to Argument/Remarks
The new examiner of record has carefully considered the instant application and previous office actions of the previous examiner. This consideration and searching has led to the new grounds of rejection in this new third non-final office action. The examiner apologizes but based on further consideration and analysis of applicant’s claims the examiner respectfully disagrees that the instant claims are allowable due to applicant’s amendments to the claims as discussed in applicant’s response based on the issues discussed above.
Conclusion
Claim 19 is allowed. All other claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN E HIRT/Primary Examiner, Art Unit 1616
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
