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 .
Response to Amendment
The Amendment filed 05/07/2026 has been entered. Claims 1 & 3-5 are pending in the application. Claim 5 is withdrawn. Claim 2 is cancelled.
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 1 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),
wherein 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 percentage of the volume of the gas 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, 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 1 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 1 above.
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).
Oda 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)
Response to Arguments
Applicant's arguments filed 05/07/2026 have been fully considered but they are not persuasive.
Regarding the 102 rejection for Claim 1, Applicant argues the claimed biomolecule and gas –with the claimed gas percentage— is not an intended use limitation, but is instead a substantive limitation of the claimed apparatus. As such, Oda does not anticipate each limitation. Examiner disagrees.
Examiner points Applicant to both MPEP 2114(II) & 2115.
The claimed apparatus is an injector, which is intended to be used to “inject a solution containing a biomolecule and a gas”. MPEP 2114(II) states an “[A]pparatus claims cover what a device is, not what a device does", and “A claim containing 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.” When considering MPEP 2114(II) in light of the instant application, the only limitations which hold any patentable weight are the limitation which contain structure pertaining to the injector, not the substance which the injector is intended to inject. As such, Oda teaches all of the claimed injector structure, and the components of the solution are not material to patentability, resulting in Oda anticipating each of the claimed patentable structural limitations.
MPEP 2115 states “"[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In the instant case, the “material or article worked upon” is the claimed biomolecule and gas –with the claimed gas percentage. As such, the claimed solution and gas percentage are not patentable limitations. And again, each of the claimed structural features of the injector –the structure being claimed—are taught by Oda.
Additionally, the Oda injector is capable of injecting the claimed solution, since Oda teaches each of the claimed structural limitations, and one of ordinary skill in the art would conclude the intended solution may be ejected from the Oda storage portion through the Oda nozzle portion.
Regarding the 103 rejection for Claim 1, Applicant argues the combination of Oda, modified by Slate, is not an obvious combination, since Slate does not teach the use of a biomolecule and a gas. Examiner disagrees with this conclusion.
Oda does teach the use of 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). Slate is relied upon to teach one of ordinary skill in the art would be motivated to optimize the percentage of the Oda air within the Oda storage portion to control momentum.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
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