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 Group I (Claims 1-10; drawn to a culture container) in the reply filed on December 31, 2024, is acknowledged.
Claims 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Group II), there being no allowable generic or linking claim.
DETAILED ACTION
The amended claims filed on September 18, 2025, have been acknowledged. Claims 1-4 and 6-10 were amended. In light of the Applicant’s elected invention, claims 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-10 are pending and examined on the merits.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d).The applicant claims foreign priority from JP2019-121816 filed on June 28, 2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received December 28, 2021. While a certified copy of the foreign patent application JP2019-121816 is provided with the instant application, a certified English translation of said foreign patent applications have not been provided.
Withdrawn Claim Objections
The prior objection of claims 2-4 and 6-10 is withdrawn because of the following changes:
Claims 2, 3 and 4 added a preposition to the phrase “such that diameter thereof”.
Claim 6 added a preposition to the phrases “length” and “diameter”.
Claim 7 added a preposition to the phrases “depth” and “diameter”.
Claim 8 added a preposition to the phrases “surface roughness” and “surface roughness”.
Claim 9 added a preposition to the phrase “angles”, “first base portion” and “second base portion”.
Claim 10 added a preposition to the phrase “length” and “length”.
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.
The prior rejection of claims 1-10 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 is withdrawn in light of Applicant’s amendments to claim 1 and 6 to recite “an opening” and clarify that the opening corresponds to the opening of the second cavity.
Claims 4 and 6-10 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 4 and 6-10 recite the limitation "a second sidewall portion" in lines 3. There is insufficient antecedent basis for this limitation in the claims. Claim 1 recites “a second sidewall portion” already. Therefore, it is unclear whether the “a second sidewall portion” of claims 4 and 6-10 are the same as the second sidewall portion recited in claim 1 or a different one.
Claim 1 should be clarified that “the opening” is in fact “the opening of the second concavity”, if this is the case.
Similarly, Claim 6 should be clarified that “the opening” is in fact “the opening of the second concavity”, if this is the case.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Japanese Patent Application No. 2008-200028 (Saito; referenced in IDS), as evidenced by Lee et al. (Theriogenology 67: 228–237. 2007).
As an initial matter, regarding the limitation “permitting culture of a regenerative hair follicle germ having a guide thread and a plurality of cells which are located at a tip portion of the guide thread”, this limitation is met as long as the container of the prior art is capable of allowing culture of mammalian cells. Additionally, hair follicle germs and the guide thread are not considered to be part of the container as there is no positive recitation that they are a part of the container. As further evidence that the thread and cells are not part of the container, claim 1 also recites that the base portion “is capable of causing the guide thread to be positioned so as to appear to be located in a central portion of the opening when the opening of the second cavity is viewed from above”. As the guide thread has not been positioned in the culture container, then neither are the cells. All that is required is that a guide thread could be placed in the container of the prior art.
Regarding claim 1, Saito teaches a reaction tube comprising a first concavity with a first base portion (see annotated image of Figure 1 of Saito) and a second concavity 14 with a second base portion 15, a second sidewall portion 20, and an opening between the sidewall portions.
Regarding the limitation “a second concavity provided below the first concavity … which opens into a central portion of the first base portion”, the first concavity (i.e. the lid of the reaction tube) is constructed to be provided above the second concavity when the lid is in an open position as seen in the first annotated image of claim 1 or when the lid is closed with the base of the reaction tube. The closed reaction tube of Figure 1 is considered to fall within this limitation as the lid portion (the first concavity and base portion) closes into the second concavity and the second concavity would open into the central portion of the first base portion.
PNG
media_image1.png
619
690
media_image1.png
Greyscale
First Annotation of Figure 1 of Saito
In regard to the preamble of Claim 1, Lee evidences that embryos can be cultured in Eppendorf tubes (abstract). As such the reaction tubes of Saito can be used for culturing mammalian cells.
In regard to the wherein clause of Claim 1, as there is an opening near the center of the tube of Saito between the sidewall portions of the reaction tube base, a guide thread could be placed within that central opening.
Regarding claim 2, as can be seen in the first annotated Figure 1 of Saito, the second base portion has a decrease in diameter as one proceeds toward a lower portion of the base.
Regarding claim 3, as can be seen in the first annotated Figure 1 of Saito, the first base portion has a decrease in diameter as one proceeds toward a lower portion of the base.
Regarding claim 4, under a first interpretation of the second sidewall portion, Figure 1 of Saito teaches that their tube further comprises a second sidewall portion 20 that is connected to the second base portion 15. The second sidewall 20 is inclined and decreases in size (I.e. diameter) as one moves to bottom of the tube (see Second Annotation of Figure 1 of Saito).
Regarding claim 5, Saito teaches conical tubes. As such, the second base portion will be conical in shape.
Regarding claim 6, the second sidewall 20 is connected to the second base portion 15 and has a length greater than the diameter of the opening between the two sidewall portions.
Claims 1-3, 6-7, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Japanese Patent Application No. 2008-200028 (Saito; referenced in IDS), as evidenced by Lee et al. (Theriogenology 67: 228–237. 2007).
As an initial matter, regarding the limitation “permitting culture of a regenerative hair follicle germ having a guide thread and a plurality of cells which are located at a tip portion of the guide thread”, this limitation is met as long as the container of the prior art is capable of allowing culture of mammalian cells. Additionally, hair follicle germs and the guide thread are not considered to be part of the container as there is no positive recitation that they are a part of the container. As further evidence that the thread and cells are not part of the container, claim 1 also recites that the base portion “is capable of causing the guide thread to be positioned so as to appear to be located in a central portion of the opening when the opening of the second cavity is viewed from above”. As the guide thread has not been positioned in the culture container, then neither are the cells. All that is required is that a guide thread could be placed in the container of the prior art.
Regarding claim 1, Saito teaches a reaction tube comprising a first concavity with a first base portion (see second annotated image of Figure 1 of Saito) and a second concavity 14 with a second base portion 15, a second sidewall portion 11, and an opening between the sidewall portions.
PNG
media_image2.png
681
829
media_image2.png
Greyscale
Second Annotation of Figure 1 of Saito
Regarding the limitation “a second concavity provided below the first concavity … which opens into a central portion of the first base portion”, the first concavity (i.e. the lid of the reaction tube) is constructed to be provided above the second concavity when the lid is in an open position as seen in the first annotated image of claim 1 or when the lid is closed with the base of the reaction tube. The closed reaction tube of Figure 1 is considered to fall within this limitation as the lid portion (the first concavity and base portion) closes into the second concavity and the second concavity would open into the central portion of the first base portion.
In regard to the preamble of Claim 1, Lee evidences that embryos can be cultured in Eppendorf tubes (abstract). As such the reaction tubes of Saito can be used for culturing mammalian cells.
In regard to the wherein clause of Claim 1, as there is an opening near the center of the tube of Saito between the sidewall portions of the reaction tube base, a guide thread could be placed within that central opening.
Regarding claim 2, as can be seen in the second annotated Figure 1 of Saito, the second base portion has a decrease in diameter as one proceeds toward a lower portion of the base.
Regarding claim 3, as can be seen in the second annotated Figure 1 of Saito, the first base portion has a decrease in diameter as one proceeds toward a lower portion of the base.
Regarding claim 6, under a second interpretation of the second sidewall portion, Figure 1 of Saito teaches that their tube further comprises a second sidewall portion 11 that is connected to the second base portion 15. The second sidewall 20 has a length greater than the diameter of the opening of the tube (see Second Annotation of Figure 1 of Saito).
PNG
media_image3.png
620
740
media_image3.png
Greyscale
Third Annotation of Figure 1 of Saito
Regarding claim 7, under a second interpretation of the second base portion, the sidewall 11 is connected to the second base portion 20 by the connecting region 15. The depth of the second base portion is less than the diameter at the top of the connecting region (see Third Annotation of Figure 1 of Saito).
Regarding claim 10, under a second interpretation of the second base portion, the sidewall 11 is connected to the second base portion 20 by the connecting region 15. The length of the second sidewall 11 is greater than the length of the second base portion 20 (see Third Annotation of Figure 1 of Saito).
Claims 1-3 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Japanese Patent Application No. 2008-200028 (Saito; referenced in IDS), as evidenced by Lee et al. (Theriogenology 67: 228–237. 2007).
As an initial matter, regarding the limitation “permitting culture of a regenerative hair follicle germ having a guide thread and a plurality of cells which are located at a tip portion of the guide thread”, this limitation is met as long as the container of the prior art is capable of allowing culture of mammalian cells. Additionally, hair follicle germs and the guide thread are not considered to be part of the container as there is no positive recitation that they are a part of the container. As further evidence that the thread and cells are not part of the container, claim 1 also recites that the base portion “is capable of causing the guide thread to be positioned so as to appear to be located in a central portion of the opening when the opening of the second cavity is viewed from above”. As the guide thread has not been positioned in the culture container, then neither are the cells. All that is required is that a guide thread could be placed in the container of the prior art.
Regarding claim 1, Saito teaches a reaction tube comprising a first concavity with a first base portion (see annotated image of Figure 3 of Saito) and a second concavity 14 with a second base portion 15, a second sidewall portion 11, and an opening.
PNG
media_image4.png
607
987
media_image4.png
Greyscale
Annotation of Figure 3 of Saito
Regarding the limitation “a second concavity provided below the first concavity … which opens into a central portion of the first base portion”, the first concavity (i.e. the lid of the reaction tube) is constructed to be provided above the second concavity when the lid is in an open position as seen in the first annotated image of claim 1 or when the lid is closed with the base of the reaction tube. The closed reaction tube of Figure 1 is considered to fall within this limitation as the lid portion (the first concavity and base portion) closes into the second concavity and the second concavity would open into the central portion of the first base portion.
In regard to the preamble of Claim 1, Lee evidences that embryos can be cultured in Eppendorf tubes (abstract). As such the reaction tubes of Saito can be used for culturing mammalian cells.
In regard to the wherein clause of Claim 1, as there is an opening near the center of the tube of Saito between the surface roughness indentations, a guide thread could be placed within that central opening.
Regarding claim 2, as can be seen in the annotated Figure 3 of Saito, the second base portion has a decrease in diameter as one proceeds toward a lower portion of the base.
Regarding claim 3, as can be seen in the third annotated Figure 3 of Saito, the first base portion has a decrease in diameter as one proceeds toward a lower portion of the base.
Regarding claim 8, as can be seen in the annotated Figure 3 of Saito, the sidewall 11 of Figure 3 is a flat surface while the second base portion 15 includes an indentation 22a (i.e. increased roughness) (see Annotation of Figure 3 of Saito).
Claims 1-4 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Japanese Patent Application No. 2008-200028 (Saito; referenced in IDS), as evidenced by Lee et al. (Theriogenology 67: 228–237. 2007).
As an initial matter, regarding the limitation “permitting culture of a regenerative hair follicle germ having a guide thread and a plurality of cells which are located at a tip portion of the guide thread”, this limitation is met as long as the container of the prior art is capable of allowing culture of mammalian cells. Additionally, hair follicle germs and the guide thread are not considered to be part of the container as there is no positive recitation that they are a part of the container. As further evidence that the thread and cells are not part of the container, claim 1 also recites that the base portion “is capable of causing the guide thread to be positioned so as to appear to be located in a central portion of the opening when the opening of the second cavity is viewed from above”. As the guide thread has not been positioned in the culture container, then neither are the cells. All that is required is that a guide thread could be placed in the container of the prior art.
Regarding claim 1, Saito teaches a reaction tube comprising a first concavity with a first base portion (see annotated image of Figure 2 of Saito) and a second concavity 14 with a second base portion 15, a second sidewall portion 20, and an opening.
PNG
media_image5.png
648
756
media_image5.png
Greyscale
Annotation of Figure 2 of Saito
Regarding the limitation “a second concavity provided below the first concavity … which opens into a central portion of the first base portion”, the first concavity (i.e. the lid of the reaction tube) is constructed to be provided above the second concavity when the lid is in an open position as seen in the first annotated image of claim 1 or when the lid is closed with the base of the reaction tube. The closed reaction tube of Figure 1 is considered to fall within this limitation as the lid portion (the first concavity and base portion) closes into the second concavity and the second concavity would open into the central portion of the first base portion.
In regard to the preamble of Claim 1, Lee evidences that embryos can be cultured in Eppendorf tubes (abstract). As such the reaction tubes of Saito can be used for culturing mammalian cells.
In regard to the wherein clause of Claim 1, as there is an opening near the center of the tube of Saito between the surface roughness indentations, a guide thread could be placed within that central opening.
Regarding claim 2, as can be seen in the annotated Figure 2 of Saito, the second base portion has a decrease in diameter as one proceeds toward a lower portion of the base.
Regarding claim 3, as can be seen in the third annotated Figure 2 of Saito, the first base portion has a decrease in diameter as one proceeds toward a lower portion of the base.
Regarding claim 4, Figure 2 of Saito teaches that their tube further comprises a second sidewall portion 20 that is connected to the second base portion 15. The second sidewall 20 is inclined and decreases in size (I.e. diameter) as one moves to bottom of the tube (see Annotation of Figure 2 of Saito).
Regarding claim 9, as can be seen in annotated Figure 2 of Saito, the tube comprises a second sidewall connected to the second base portion and the second base portion, the second sidewall, and the first base portion are inclined related to the vertical direction. As can be seen in annotated Figure 2, the angles of the first base portion and second base portion with respect to the vertical direction are greater than the angle of the second sidewall portion with respect to the vertical direction.
Response to Arguments
Applicant's arguments filed September 18, 2025, are acknowledged.
Applicant argues that he amendments to claim 1 overcome the rejections based on Saito. Applicant argues the claims are clearly distinct (page 8, paragraphs 2-3).
Applicant's arguments have been fully considered but they are not persuasive.
Although Applicant argues that the amended claims are clearly distinct from the art of Saito, Applicant does not cite any specific differences between the amended claims and the art of Saito. As stated above, the art of Saito teaches all of the limitations of the amended claims. Therefore, the Applicant’s arguments are considered unpersuasive.
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 KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Doug Schultz can be reached on (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEENAN A BATES/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631