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 .
Claim Status
Claims 1-9, 11-14, and 22-27 are pending.
Receipt is acknowledged of Applicant’s claim amendments and arguments submitted on 16 December, 2025. Claim 1 is amended.
Applicant's election with traverse of the invention of group I drawn to a method of making cryopreserved rat sperm (claims 1-9) in the reply filed on 16 December, 2025 is acknowledged. The traversal is on the grounds that the inventions of groups I and II share the technical feature of a step of subjecting the sperm suspension to a cooling condition of lower than 1 degree C prior to freezing. This is not found persuasive because the inventions of groups I and II do not share this technical feature. The invention of group I requires lower than 1 degree C while the invention of group II (1) does not share dependency with the invention of group I and (2) instead requires “about” 1 degree C or lower. As noted by Applicant, “Nakagata involves ‘cooling the sperm suspension filled in a cryopreservation tube to 1-10 [degrees]C,’”. This disclosure encompasses “about” 1 degree C. Therefore, even were the shared technical feature to be the step of subjecting the sperm suspension to a cooling condition (which differs between groups I and II), Nakagata discloses this shared technical feature, precluding its identification as a special technical feature, and the inventions of Groups I and II still lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-14, and 22-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
It is noted that when a final requirement for restriction is made by the examiner, applicant may file a petition under 37 CFR 1.144 for review of the restriction requirement. The propriety of a requirement to restrict, if traversed, is reviewable by petition under 37 CFR 1.144 . In re Hengehold, 440 F.2d 1395, 169 USPQ 473 (CCPA 1971).
Therefore, claims 1-9 are pending and under examination in the present Official Action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/JP2020/047732, filed 21 December, 2020, which claims priority to Japan Application No. JP2019-231190, filed 23 December, 2019. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Certified untranslated copies of papers required by 37 CFR 1.55 have been filed in this application on 21 June, 2022.
The earliest possible priority for the instant application is 23 December, 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 28 May, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because the text in figure 1 is out of focus to a degree which renders portions of the figure illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-9 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 1 recites the limitation "the rat cauda epididymis" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 is an independent claim and nowhere within claim 1 is there a recitation of a rat cauda epididymis which may properly be relied upon as providing antecedent for “the rat cauda epididymis”.
Claim 1 is further rejected for being unclear in its recitation of “maintaining the suspension”. It is unclear whether Applicant intends the scope of claim 1 to encompass maintaining the suspension at a non-freezing temperature of lower than 1 °C for about 15 minutes to about 40 minutes or whether Applicant instead intends some other meaning behind the use of the term “maintaining” which might allow for the temperature to raise above 1 °C. For example: it is unclear whether “maintaining” as used in claim 1 requires the mere maintenance in solution of the sperm or maintaining the viability of the sperm or whether it requires the maintenance of the non-freezing temperature of lower than 1 °C instead.
Claim 2 is unclear because it is unclear whether the claim requires the movement of rat sperms to be reduced or whether the claim is merely setting forth the purpose behind the cooling step (in which case, claim 2 does not further limit claim 1). A person having ordinary skill in the art would not be apprised of the scope of the patent protection sought by claim 2 insofar as they would not know whether the movement of sperms is actually required to be reduced.
Claim 2 is also indefinite in the recitation of the phrase “substantially reducing” since it is unclear how this term “substantially” is defined, what its metes and bounds are, or to what the term is directed towards. It is not clear in reference to what extent reducing the movement of rat sperms is completed
Claims 3-5 are rejected for being indefinite because it is unclear whether the terms appearing in parentheticals are intended to limit the scope of the instant invention. Claim 3 recites “wherein the cooling comprises (b-1)…and (b-2)…”, claim 4 recites “wherein in (b-2)…” and claim 5 recites “wherein the further cooling in (b-2)…”. Claim 1 from which each of claims 3-5 depends directly or indirectly recites a method comprising steps “a”, “b”, and “c” wherein step “b” is a step of “cooling the rat sperm suspension to a non-freezing temperature of lower than 1 °C and maintaining the suspension for about 15 minutes to about 40 minutes”. It is unclear whether the limitations in parentheses are meant to be limitations in the claims or whether they are only suggestions/examples. As such, the metes and bounds of the claims cannot be determined.
Claim 4 is indefinite in the recitation of “the further cooling” in line 1. There is not proper antecedent bases for the phrase “the further cooling” in claim 1.
Claim 9 is unclear in its recitation of “derived from a gene-modified rat”. It is unclear what steps or characteristics are required to be considered “derived from” in this context. Therefore, a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought by claim 9. This rejection can be overcome by reciting “isolated from” in place of “derived from”.
35 U.S.C. 112, (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 depends from claim 1. Claim 1 , step b: requires that a non-freezing temperature of lower than I °C. Claim 3 broadens the scope of the claimed cooling the primarily cooled sperm suspension in claim 1, step b: to about I °C or lower
Applicant may cancel the claim, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 depends from claim 1. Claim 1 requires “maintaining the suspension for about 15 minutes to about 40 minutes”. Claim 5 broadens the scope of the claimed maintenance on ice to for about 15 minutes to about 45 minutes.
Applicant may cancel the claim, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Additional Comments
The closest prior art to the instant invention is JP2005-002058 (referring to the English language translation provided by Applicant on the IDS of 28 May, 2024) (hereinafter “Nakagata”). Nakagata claims a method of cryopreserving rat sperm comprising a step of cooling the rat sperm in a suspension to 1-10 °C, then a step of freezing the rat sperm suspension at -80 °C (Nakagata, [Claim 1]). Nakagata also claims that the cooling step is to be within 2-8 °C for 5 to 30 minutes (Nakagata, [Claim 2]). Nakagata specifies that the rat sperm is from the rat cauda epididymis (Nakagata, [0027]). However, the particular method taught in Nakagata involves cooling the rat sperm suspension to 5 °C prior to freezing (Nakagata, [0038], [0040], [0041]). Nakagata does not specifically teach or suggest to cool the rat sperm suspension to a non-freezing temperature of lower than 1 °C before freezing it.
James teaches the state of the art for cryopreserving epididymal sperm and teaches that the challenge with cryopreservation of sperm is the ability for those sperm to survive an intermediate zone of temperatures between -10 and -50 °C (James, Louisiana State University and Agricultural & Mechanical College, 2004, page 22, first full paragraph). James teaches methods for different species wherein sperm solution is cooled to 4 °C before being flash frozen in liquid nitrogen (James, pages 23-26). In none of the methods taught by James is the sperm suspension cooled to a non-freezing temperature of lower than 1 °C and maintained at that temperature for about 15 minutes to about 40 minutes.
Therefore, claims 1-9 are indicated as free of the prior art of record.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN THOMAS TINSLEY whose telephone number is (703)756-5906. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA G LEAVITT can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634