DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed October 30, 2025, has been received and entered.
Claims 8, 9, and 13 are canceled.
Claims 1-7 and 10-12 are pending. Claims 1-6 are withdrawn.
Claims 7 and 10-12 are examined on the merits.
Claim Objections
Claims 7 and 10-12 are objected to because of the following informalities:
Claim 7 is objected to because it recites “plate-rich” in line 18 which is a misspelling of the term “platelet-rich.” Since claim 7 is objected to, then its dependent claims, claims 10-12, are objected to.
Appropriate correction is required.
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 7 and 10-12 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 7 is rendered indefinite by the recitation “the syringe” in line 15 (in the collecting step). Claim 7 recites “one or more syringes” in line 6 which encompasses the embodiment of multiple syringes. For that embodiment, it is unclear whether only one, some, or all of the syringes are used in the steps after the step of providing a device (i.e., the steps of collecting a platelet-rich plasma, etc.).
Additionally, claim 7 is rendered indefinite by the recitation “the receptacle” in line 16. Claim 7 first recites “one or more receptacles” in line 5, which encompasses the embodiment of multiple receptacles. For that embodiment, it is unclear whether the syringe is placed in only one, some, or all of the receptacles. This rejection can be overcome by amending “the receptacle” in line 16 to “a receptacle.”
The term “excessive or undesired heat levels” in claim 7 is a relative term which renders the claim indefinite. The term “excessive or undesired heat levels” 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. It is unclear what heat levels are considered “excessive,” and it is unclear what heat levels are considered “undesired.” Moreover, it is unclear what signifies that a heat level is “undesired” since “undesired” is a subjective term. See MPEP 2173.05(b), particularly MPEP 2173.05(I) and MPEP 2173.05(IV).
Since claim 7 is indefinite, then its dependent claims, claims 10-12, are rendered indefinite. Therefore, claims 7 and 10-12 are rejected under 35 U.S.C. 112(b).
Claim 10 recites the limitation "the one or more containers" in the last two lines. There is insufficient antecedent basis for this limitation in the claim. Parent claim 7 does not recite “one or more containers,” and instead recites “one or more syringes.” For the purpose of applying prior art, the “one or more containers” of claim 10 are being interpreted as the “one or more syringes” of claim 7.
Notice Re: Prior Art Available Under Both Pre-AIA and AIA
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.
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.
Claims 7, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (CN 111575231. Machine Translation cited below) in view of Medendorp (WO 2020/242971. Previously cited).
Wu discloses a method for preparing a platelet-rich plasma (PRP) component of mesenchymal stem cell culture medium characterized by irradiating platelet-rich plasma with red, green, and yellow light (claim 1 of Wu on page 1). The PRP component of the mesenchymal stem cell culture medium is activated by irradiation of red, green, and yellow light rays (page 2, second-to-last paragraph). Therefore, Wu teaches a method for activating platelet-rich plasma sample (PRP), meeting a limitation of the claimed invention. The PRP component is irradiated by LED red, green, and yellow light sources at the same time (page 3, first paragraph under Section 2.2 irradiation treatment). Since the red, green, and yellow light have different wavelengths (see page 3, first paragraph under Section 2.1 light source parameters), then the combination of the red, green, and yellow light is directed to polychromatic light.
The device of Figure 1 of Wu meets limitations of the claimed device of the first step of instant claim 7. In particular, the device of Wu comprises an outer cover 1 (page 3, second-to-last paragraph) which is directed to the claimed ‘housing.’ The channel 7 of the device is directed to the claimed ‘one or more receptacles in the housing’ because a needle cylinder, i.e., syringe, is placed inside channel 7 (page 3, second-to-last paragraph; page 4, second paragraph). The LED light sources provided in the lamp holders 6 are directed to the claimed ‘at least one lamp configured to generate the polychromatic light in a predetermined light spectrum.’ Furthermore, Wu teaches that their device comprises ten of each of the red, green, and yellow LED light sources (page 3, first paragraph under Section 2.1 light source parameters; page 4, first paragraph). Thus, Wu meets some of the limitations of the lamp of instant claim 7 since the LED light sources is directed to a lamp comprising a combination of ten red lights, ten green lights, and ten yellow lights. As such, Wu teaches providing a device which meets limitations of the first step of instant claim 7.
The method of Wu comprises putting the PRP component into a transparent syringe (page 3, first paragraph under Section 2.2 irradiation treatment). This is directed to the second step of instant claim 7 of collecting a platelet-rich plasma sample in a syringe.
Wu further teaches enabling the syringe (i.e. needle cylinder) to enter the channel 7 (directed to the claimed ‘one or more receptacles’) (page 4, second and third paragraphs). This is directed to the third step of instant claim 7 of placing the syringe in the receptacle of the one or more receptacles.
Then, the transparent syringe is irradiated by the LED red, green, and yellow light sources at the same time for 20 minutes, during which the syringe is rotated so that the LED light irradiation is uniform (page 3, first paragraph under Section 2.2 irradiation treatment; page 4, second paragraph). This is directed to the second-to-last step of instant claim 7 of exposing the platelet-rich plasma sample in the syringe to the polychromatic light for a pre-determined duration (duration of 20 minutes for Example 1 of Wu). Since uniform LED light irradiation is obtained, then the channel 7 which holds the syringe (directed to the claimed ‘one or more receptacles’) is dimensioned so that the PRP sample in the syringe is fully and evenly exposed to polychromatic light, meeting further limitations of the ‘one or more receptacles’ of the device of instant claim 7. Given that the syringe of Wu is irradiated by the LED light sources at the same time, then the LED light sources (directed to the claimed lamp) are positioned to expose a syringe in a respective receptacle (the channel 7 of Wu) to the polychromatic light, meeting a further limitation of the ‘at least one lamp’ of the device of instant claim 7.
Additionally, Wu teaches that their device comprises a fan 5 (page 3, second-to-last paragraph). The fan 5 can dissipate heat, and when the temperature reaches 25ºC, the fan can be automatically started so that the temperature of the cells under irradiation of the LED lamp is ensured to be stably lower than 37ºC (page 4, second paragraph). This is directed to the last step of instant claim 7 of controlling temperature within predefined limits to prevent exposure of the PRP sample to excessive or undesired heat levels (e.g., above 25ºC, or 37ºC or more, as taught in Wu) while exposing to the polychromatic light.
Wu differs from the claimed invention in that Wu does not expressly disclose that their LED light sources further comprise ten blue lights.
Medendorp discloses increasing the concentration of a growth factor in a platelet-rich plasma sample by irradiating the sample with light with a wavelength of at least about 600 nm, such as about 600 nm to about 1500 nm (paragraph [0042]). In some embodiments, combinations of wavelengths are used (paragraph [0043]). The increase in growth factor concentration in platelet-rich plasma (PRP) is directed to activating PRP. Additionally, Medendorp teaches that specific wavelengths of visible light known to destroy bacteria, such as intense blue light of between 400 and 500 nm, may also be administered to disinfect the PRP (paragraph [00159]).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to further include ten LED blue light sources with the other light sources in the device of Wu such that the syringe comprising PRP is also irradiated with blue light when performing the method of Wu. One of ordinary skill in the art would have been motivated to do this in order to disinfect the PRP; the destruction of bacteria in the PRP would have been desirable for the product of Wu. There would have been a reasonable expectation of activating PRP by the modification because Medendorp further administered blue light for an invention of activating PRP by irradiation of light of combinations of wavelengths. Additionally, it would have been obvious to provide ten of an LED blue light source for the method rendered obvious by Wu in view of Medendorp because ten of each of the other light sources (red, green, and light) were included in the device of Wu, and because it would have been prima facie obvious to the skilled artisan to vary the number of the LED blue light source, including to ten LED blue light sources, for the predictable result of producing the blue light. Therefore, instant claim 7 is rendered obvious.
Regarding instant claim 11, Wu teaches that their device comprises a time reduction control key 8 and a time increase control key 9 (page 3, paragraph above the ‘Detailed Description’ section). The irradiation time can be reduced or increased by reducing the time control key 8 or increasing the time control key 9 (page 4, second paragraph). Therefore, the time reduction control key 8 and the time increase control key 9 are together directed to the claimed ‘timer to set a duration of polychromatic light exposure.’ Thus, instant claim 11 is rendered obvious.
Regarding instant claim 12, Wu teaches that their device comprises a time reduction control key 8, a time increase control key 9, and a light crystal display screen 4 (page 3, paragraph above the ‘Detailed Description’ section). The light crystal display screen 4 is directed to the claimed ‘one or more displays.’ Furthermore, the irradiation time can be reduced or increased by reducing the time control key 8 or increasing the time control key 9 (page 4, second paragraph). Therefore, the time reduction control key 8 and the time increase control key 9 are directed to the claimed ‘one or more control buttons’ which are ‘configured to set a duration of keeping the at least one lamp turned on.’ As such, instant claim 12 is rendered obvious.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wu and Medendorp as applied to claims 7, 11, and 12 above, and further in view of Kinkaid (US 2010/0255458).
As discussed above, Wu in view of Medendorp renders obvious claims 7, 11, and 12. Regarding claim 10, the outer cover 1 of Wu is directed to the claimed ‘housing,’ and the space inside the outer cover 1 of Wu is directed to the claimed ‘chamber encased within the housing.’ The LED lamp tube 2 of Wu, comprising lamp holders 6, is positioned in the outer cover 1 (page 3, second-to-last paragraph; Figures 1 and 2). Therefore, Wu meets the limitation of claim 10 of ‘wherein the at least one lamp protrudes into the chamber.’ Also, the channel 7 for accommodating the needle tube, i.e. syringe, is arranged in the LED lamp tube 2 in Wu (page 3, second-to-last paragraph; Figures 1 and 2). Therefore, Wu also meets the limitation of claim 10 of ‘the one or more receptacles are provided in the chamber’ (the channel 7 of Wu is directed to the claimed ‘one or more receptacles’).
Wu in view of Medendorp differs from claim 10 in that they do not expressly disclose that the inner surface of their chamber has a reflective coating for evenly exposing the one or more syringes (the Examiner’s interpretation of ‘the one or more containers’) to the polychromatic light.
Kinkaid discloses an invention relating to the design of bioreactors (abstract). The invention includes methods for supplying light to a bioreactor for growth of a photoautotrophic organism, including utilizing artificial light sources (paragraph [0198]). In some embodiments of the invention, the methods for supplying light can include utilizing a bioreactor with a reflective coating on the interior surfaces of the bioreactor (paragraph [0199]). The reflective surface can reduce the amount of light loss due to or through the materials of the bioreactor (paragraph [0199]).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to include a reflective coating on the interior surfaces of the outer cover 1 of Wu when performing the method rendered obvious by Wu in view of Medendorp. One of ordinary skill in the art would have been motivated to do this in order to reduce the amount of light loss due to or through the outer cover 1 of Wu, thereby ensuring full irradiation of the PRP for its activation. Reducing the amount of light loss is directed to evenly exposing the syringe to the polychromatic light (the combination of the light from the light sources). Therefore, instant claim 10 is rendered obvious.
Response to Arguments
Applicant’s arguments, filed October 30, 2025, with respect to the rejection under 35 U.S.C. 112(b) of claims 8 and 9, the rejection under 35 U.S.C. 102(a)(1) of claim 13 as being anticipated by Irmak, the rejection under 35 U.S.C. 103 of claims 7 and 10-13 as being unpatentable over Medendorp, the rejection under 35 U.S.C. 103 of claims 8 and 9 as being unpatentable over Medendorp in further view of Mars, and the rejection under 35 U.S.C. 103 of claims 7 and 10-12 as being unpatentable over Irmak in view of Medendorp, have been fully considered and are persuasive. In particular, the rejection under 35 U.S.C. 112(b) has been rendered moot by the canceling of claims 8 and 9. The rejection under 35 U.S.C. 102(a)(1) over Irmak and the rejection under 35 U.S.C. 103 over Irmak in view of Medendorp have been overcome by the amendment to claim 7 since Irmak does not disclose using a lamp comprising a combination of ten red lights, ten blue lights, ten green lights, and ten yellow lights, or a syringe for collection and exposure of PRP to the polychromatic light in a device. The rejections under 35 U.S.C. 103 over Medendorp (including its combination with Mars) have been overcome by the amendment to claim 7 since Medendorp does not disclose using a lamp comprising a combination of ten red lights, ten blue lights, ten green lights, and ten yellow lights, or a syringe for collection and exposure of PRP to the polychromatic light in their device. Therefore, these rejections have been withdrawn.
However, upon further consideration, new grounds of rejection are made in view of Wu, in combination with the previously cited Medendorp and the newly cited Kinkaid as secondary references. The amendments to the claims necessitated new rejections under 35 U.S.C. 103 and 35 U.S.C. 112(b).
Conclusion
No claims are allowed.
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.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651