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 Invention I in the reply filed on 01/14/2026 is acknowledged.
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 01/14/2026.
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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oda (U.S. PGPub 2018/0304019), as evidenced by biologydictionary.net/dna/ (see DNA - Definition, Function, Strucuture and Discovery _ Biology Dictionary pdf from web.archive.org/web/20190124182623/https://biologydictionary.net/dna/#google_vignette showing a published date of 01/24/2019). See parallel rejection for Claim 2 below.
As to Claim 1, Oda teaches an injector (10) configured to inject a solution (the dosing liquid described in Paragraph 0042) containing (note the use of particular components in the solution is considered intended use; see end of paragraph for clarification) a biomolecule (DNA; Paragraph 0041, as evidenced by biologydictionary.net/dna/, where one of ordinary skill in the art would conclude a biological macromolecule –under the DNA Definition section-- is a biomolecule) and a gas (air; Paragraph 0135) that is predetermined (as described in Paragraphs 0041/0135) into an injection target (the object region described in Paragraph 0040) without using an injection needle (Paragraph 0048, where the injection port 31a is pressed directly against the object region without the use of a needle), the injector (10) comprising:
a storage portion (32) configured to store (Paragraph 0042) the solution (the dosing liquid described in Paragraph 0042) containing (intended use) the biomolecule (DNA; Paragraph 0041) and the gas (air; Paragraph 0135);
a nozzle portion (31) communicating with (as shown in Figure 1; Paragraph 0045) the storage portion (32), the nozzle portion (31) including (as shown in Figure 1) an ejection port (31a) configured to eject (as described in Paragraph 0048) the solution (the dosing liquid described in Paragraph 0042) containing (intended use) the biomolecule (DNA; Paragraph 0041) and the gas (air; Paragraph 0135) toward (as described in Paragraph 0048) the injection target (the object region described in Paragraph 0040); and
a pressurization portion (4/5) configured to pressurize (via pressing plunger 4 within storage chamber 32, as described in Paragraph 0045) the solution (the dosing liquid described in Paragraph 0042) containing (intended use) the biomolecule (DNA; Paragraph 0041) and the gas (air; Paragraph 0135) that are stored (Paragraph 0042) in the storage portion (32) during an operation (the operation performed in Paragraph 0045) and to eject (Paragraph 0045) the solution (the dosing liquid described in Paragraph 0042) containing (intended use) the biomolecule (DNA; Paragraph 0041) and the gas (air; Paragraph 0135) from (as described in Paragraph 0045) the ejection port (31a) toward (as described in Paragraph 0048) the injection target (the object region described in Paragraph 0040).
The intention to use a selected fluid with particular components –i.e., a biomolecule and gas as the solution-- in the injector is not a patentable limitation, as a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647; MPEP 2114(II). Also see MPEP 2115. Additionally, the Oda injector is capable of injecting the solution with the claimed components.
As to Claim 2, Oda teaches all the limitations of Claim 1, and continues to teach a volume of the gas stored in the storage portion is equal to or greater than 20% and equal to or less than 60% of a capacity of the storage portion. The volume of the gas stored in the storage portion with respect to the capacity of the storage portion is considered intended use.
The intention to use a selected fluid with particular components –i.e., a biomolecule and gas as the solution, where the gas is between 20% and 60% of the storage portion capacity-- in the injector is not a patentable limitation, as a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647; MPEP 2114(II). Also see MPEP 2115. Additionally, the Oda injector is capable of injecting the solution with the claimed components at the claimed percentages.
As to Claim 3, Oda teaches all the limitations of Claim 1, and continues to teach the gas (air; Paragraph 0135) is (intended use) air (air; Paragraph 0135). The intention to use a selected fluid with particular components –i.e., a biomolecule and gas/air as the solution-- in the injector is not a patentable limitation, as a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647; MPEP 2114(II). Also see MPEP 2115. Additionally, the Oda injector is capable of injecting the solution with the claimed components.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oda (U.S. PGPub 2018/0304019), as evidenced by biologydictionary.net/dna/, as further evidenced by en.wikipedia.org/wiki/DNA (see DNA – Wikipedia pdf from web.archive.org/web/20200102003437/https://en.wikipedia.org/wiki/DNAshowing a published date of 01/02/2020).
As to Claim 4, Oda teaches all the limitations of Claim 1, and continues to teach the biomolecule (DNA; Paragraph 0041) is (intended use) DNA (DNA; Paragraph 0041) containing a gene (as evidenced by en.wikipedia.org/wiki/DNA, which describes all DNA as being comprised of genes – see Biological functions section). The intention to use a selected fluid with particular components –i.e., a biomolecule/DNA and gas/air as the solution-- in the injector is not a patentable limitation, as a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647; MPEP 2114(II). Also see MPEP 2115. Additionally, the Oda injector is capable of injecting the solution with the claimed components.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Oda, as evidenced by biologydictionary.net/dna/, in view of Slate (U.S. Patent 6,645,169). See parallel rejection for Claim 2 above.
As to Claim 2, Oda teaches all the limitations of Claim 1, but is silent on the percent of gas in the storage portion, so does not explicitly teach a volume of the gas stored in the storage portion is equal to or greater than 20% and equal to or less than 60% of a capacity of the storage portion.
Slate describes a similar injector, and teaches the relative size of the volume of the gas (the size of the gas pocket 22, described in Column 4, Line 66, to Column 5, Line 12) in the storage portion 12 is a result-effective variable (see MPEP 2144.05(II)(B)) which affects the momentum of the solution (the fluid medicament 24 described in Column 5, Lines 25-42) which affects the size of the hole in the injection target (the skin of the patient, as described in Column 1, Line 54, to Column 2, Line 3).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to make the volume of the gas stored in the storage portion equal to or greater than 20% and equal to or less than 60% of a capacity of the storage portion, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. (1955)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lavi (2002/0007671) and Lavi (2004/0069044) describe using air in a similar injector storage portion to control the pressure of an injected solution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783