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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/18/26 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 5/18/26. As directed by the amendment: claims 9, 11, 12, and 14 have been amended, claims 1-8 have been cancelled, and new claims 15 and 16 have been added. Thus, claims 9-16 are presently pending in this application.
Claim Rejections - 35 USC § 112
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 9-16 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.
Regarding claims 9 and 11, the limitation “wherein the liquid type plasma induces migration of human umbilical vein endothelial cells (HUVECs) via activation of endothelial nitric oxide synthase (eNOS)” is indefinite, as it is not clear if this limitation is intended to recite a step of the method or a material property of the liquid type plasma. If the limitation were treated as reciting a particular method step, it is further unclear how induction of HUVECs migration would be achieved by the methodology as claimed without any context in the claims for the origin within/without of the subject of the HUVECs, or whether the limitation requires HUVECs in the subject at all. For the purposes of examination, the limitation will be treated as reciting an inherent property of the liquid type plasma prepared as claimed elsewhere in the claim.
Additionally, regarding claim 9, the subject is particularly recited as a subject other than a human, further complicating the contextual issue regarding
Remaining claims are rejected as dependent from claim 9 or 11 as rejected above.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9-16, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 20200254008).
Regarding claim 9, as best understood, Kim et al. discloses Kim et al. discloses a method for preventing or treating angiogenesis-related diseases (method of par. 0022-0024; treatment of keloids as a form of wound treatment, par. 0009, keloids being linked to abnormal/disregulated angiogenesis), the method comprising administering a liquid type plasma to a subject other than a human (par. 0022-0024), wherein the wherein the liquid type plasma induces migration of human umbilical vein endothelial cells (HUVECs) via activation of endothelial nitric oxide synthase (eNOS) (Kim et al., having disclosed/taught liquid type plasma as claimed, thus covers this claimed material property of liquid type plasma); wherein the liquid type plasma is prepared by a method (method of par. 0022; treatment of keloids as a form of wound treatment, par. 0009, keloids being linked to abnormal/disregulated angiogenesis), the method comprising: (a) filling a plasma generator with a carrier gas that comprises nitrogen (N2) (par. 0022; in particular where one of the carrier gas options is chosen, and that one is nitrogen); (b) generating plasma by supplying a voltage of 1 kV to 10 kV (par. 0022 and 0032) and a frequency of 10 to 30 kHz (par. 0022) to the plasma generator; and (c) irradiating a liquid material with the generated plasma for 10 to 60 seconds per ml (par. 0022), except for specifically within the range of 5 minutes to 120 minutes. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a specific amount of time, such as a time between 5 to 120 minutes, based on volume of liquid material being irradiated that would require a time of between 5 to 120 minutes based on the provided relationship of 10 to 60 second per ml, as taught by Kim et al. (par. 0022).
Additionally, there is no evidence of record that establishes that changing the time would result in a difference in function of the Kim et al. method. Further, a person having ordinary skill in the art, being faced with modifying the needle of Kim et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed time (see again the relationship set forth in par. 0022 of Kim et al.). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the irradiation step “may” be performed within the claimed time range (pg. 11) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the irradiation time of Kim et al. to be between 5 to 120 minutes as an obvious matter of design choice within the skill of the art
Regarding claim 10, Kim et al. discloses the angiogenesis-related disease is at least one disease selected from the group consisting of wounds, burns, varicose veins, ischemia, infertility, diabetic foot ulcers, ischemic stroke, ulcers, arteriosclerosis, myocardial infarction, angina pectoris, ischemic heart failure, bedsores, alopecia and cerebrovascular dementia (wounds, par. 0009).
Regarding claim 11, Kim et al. discloses a method for preventing or treating angiogenesis-related disease in a subject (par. 0009), comprising administering a pharmaceutical composition comprising a liquid type plasma prepared by the method of claim 1 as an active ingredient to a subject (use of par. 0022-0024; treatment of keloids as a form of wound treatment, par. 0009, keloids being linked to abnormal/disregulated angiogenesis).
Regarding claim 11, as best understood, Kim et al. discloses Kim et al. discloses a method for preventing or treating angiogenesis-related diseases (method of par. 0022-0024; treatment of keloids as a form of wound treatment, par. 0009, keloids being linked to abnormal/disregulated angiogenesis), comprising administering a pharmaceutical composition comprising a liquid type plasma as an active ingredient to a subject (use of par. 0022-0024; treatment of keloids as a form of wound treatment, par. 0009, keloids being linked to abnormal/disregulated angiogenesis), wherein the wherein the liquid type plasma induces migration of human umbilical vein endothelial cells (HUVECs) via activation of endothelial nitric oxide synthase (eNOS) (Kim et al., having disclosed/taught liquid type plasma as claimed, thus covers this claimed material property of liquid type plasma); wherein the liquid type plasma is prepared by a method (method of par. 0022; treatment of keloids as a form of wound treatment, par. 0009, keloids being linked to abnormal/disregulated angiogenesis) comprising: (a) filling a plasma generator with a carrier gas that comprises nitrogen (N2) (par. 0022; in particular where one of the carrier gas options is chosen, and that one is nitrogen); (b) generating plasma by supplying a voltage of 1 kV to 10 kV (par. 0022 and 0032) and a frequency of 10 to 30 kHz (par. 0022) to the plasma generator; and (c) irradiating a liquid material with the generated plasma for 10 to 60 seconds per ml (par. 0022), except for specifically within the range of 5 minutes to 120 minutes. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a specific amount of time, such as a time between 5 to 120 minutes, based on volume of liquid material being irradiated that would require a time of between 5 to 120 minutes based on the provided relationship of 10 to 60 second per ml, as taught by Kim et al. (par. 0022).
Additionally, there is no evidence of record that establishes that changing the time would result in a difference in function of the Kim et al. method. Further, a person having ordinary skill in the art, being faced with modifying the needle of Kim et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed time (see again the relationship set forth in par. 0022 of Kim et al.). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the irradiation step “may” be performed within the claimed time range (pg. 11) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the irradiation time of Kim et al. to be between 5 to 120 minutes as an obvious matter of design choice within the skill of the art
Regarding claim 12, Kim et al. discloses the pharmaceutical composition is an oral formulation, a parenteral formulation or a topical formulation (par. 0023).
Regarding claim 13, Kim et al. discloses the pharmaceutical composition is administered alone or in combination with surgery, radiation therapy, hormone therapy, chemotherapy and a biological response modifier (par. 0023).
Regarding claim 14, Kim et al. discloses the angiogenesis-related disease is selected from the group consisting of wounds, burns, varicose veins, ischemia, infertility, diabetic foot ulcers, ischemic stroke, ulcers, arteriosclerosis, myocardial infarction, angina pectoris, ischemic heart failure, bedsores, alopecia and cerebrovascular dementia (par. 0009).
Regarding claims 15 and 16, Kim et al. discloses the liquid material in Step (c) is water, saline, a buffer, or a medium (par. 0022).
Response to Arguments
Applicant's arguments filed 5/18/26 have been fully considered but they are not persuasive.
Applicant argues on pages 4-6 of the Remarks that Kim et al. does not disclose “angiogenesis-related disease” as claimed because of a special definition of that phrase provided by applicant on pg. 5, ln. 25 – pg. 6, ln. 3 of the specification. Examiner respectfully disagrees on two points: 1) the cited passage does not limit “angiogenesis-related diseases” to the definitions supplied by applicant, since it is written to be open-ended, finishing with the language “but is not limited thereto”; 2) wound treatment, which is disclosed by Kim et al., is a specific example of an angiogenesis-related disease provided in the application (see, for example, claim 14).
Applicant argues on pages 6-8 of the Remarks that the newly recited limitations of claims 9 and 14, related to cell migration, are not disclosed or taught by Kim et al. Examiner respectfully disagrees. It is not clear that the new limitations particularly recite cell migration or a method step at all, see rejections under 35 U.S.C. 112(b) above. Based on the wording of the limitations, as best understood, there is no methodology or context provided in the claims that would require any particular steps beyond providing the composition/plasma as claimed, and, as noted in the rejections above, Kim et al. provides the composition/plasma.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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