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 .
Status of the Claims
Applicant’s submission filed 26 January 2026 has been entered. Claims 37, 39-43, 49-54, 67-68, and 70-73 are pending. Claims 37, 39, 41, 49-53, and 67-68 have been amended, while claims 38, 45-48, 55, 65-66, and 69 have been cancelled without prejudice or disclaimer and claims 70-73 have been newly added. Therefore, prosecution on the merits continues for claims 37, 39-43, 49-54, 67-68, and 70-73. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to claims 37, 52, and 65
The cancellation of claims 65 renders the objection of record moot for that claim. For the remaining claims, Applicant’s amendments to instant claims 37 and 52 correct the minor informalities of each claim, thus obviating the objections of record.
Therefore, the objections are withdrawn.
RE: Rejection of claims 37-43, 45-55, and 65-69 under 35 USC 112(a)
The cancellation of claims 38, 45-48, 55, 65-66, and 69 render the rejection of record moot for those claims. For the remaining claims, Applicant’s amendments to independent claims 37 and 52 removing the limitation wherein the preserving composition does not comprise a liposome obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 37-39, 41, 45-51, and 65-68 under 35 USC 103 over Purdy et al as evidenced by Dicker et al, in view of Shahverdi et al as evidenced by BioXcell®
The cancellation of claims 38, 45-48, and 65-66 render the rejection of record moot for those claims. For the remaining claims, Applicant’s amendments to independent claim 37 requiring the preserving composition to consist of a cholesterol: cyclodextrin complex (CC complex), a biological buffer, a cryoprotectant, a carbohydrate, and a cell permeable anti-oxidant peptide, wherein the CC complex comprises cholesterol and methyl β-cyclodextrin at a weight ratio of about 90 mg cholesterol to about 1 g methyl β-cyclodextrin, obviate the rejection of record. It is of note that Applicant’s amendments have narrowed the claim scope through the transitional phrase, as well as introduced the new limitation of requiring a carbohydrate within the claimed preserving composition.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 37-39, 41-43, 45-51, and 65-68 under 35 USC 103 over Purdy et al as evidenced by Dicker et al, in view of Shahverdi et al as evidenced by BioXcell®, and further in view of Sigma
The cancellation of claims 38, 45-48, and 65-66 render the rejection of record moot for those claims. For the remaining claims, Applicant’s amendments to independent claim 37 requiring the preserving composition to consist of a cholesterol: cyclodextrin complex (CC complex), a biological buffer, a cryoprotectant, a carbohydrate, and a cell permeable anti-oxidant peptide, wherein the CC complex comprises cholesterol and methyl β-cyclodextrin at a weight ratio of about 90 mg cholesterol to about 1 g methyl β-cyclodextrin, obviate the rejection of record. It is of note that Applicant’s amendments have narrowed the claim scope through the transitional phrase, as well as introduced the new limitation of requiring a carbohydrate within the claimed preserving composition.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 37-41, 45-51, and 65-68 under 35 USC 103 over Purdy et al as evidenced by Dicker et al, in view of Shahverdi et al as evidenced by BioXcell®, and further in view of Dicker et al
The cancellation of claims 38, 45-48, and 65-66 render the rejection of record moot for those claims. For the remaining claims, Applicant’s amendments to independent claim 37 requiring the preserving composition to consist of a cholesterol: cyclodextrin complex (CC complex), a biological buffer, a cryoprotectant, a carbohydrate, and a cell permeable anti-oxidant peptide, wherein the CC complex comprises cholesterol and methyl β-cyclodextrin at a weight ratio of about 90 mg cholesterol to about 1 g methyl β-cyclodextrin, obviate the rejection of record. It is of note that Applicant’s amendments have narrowed the claim scope through the transitional phrase, as well as introduced the new limitation of requiring a carbohydrate within the claimed preserving composition.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 52-53, 55, and 69 under 35 USC 103 over Richard et al as evidenced by Dicker et al, in view of Shahverdi et al as evidenced by BioXcell®
The cancellation of claims 55 and 69 render the rejection of record moot for those claims. For the remaining claims, Applicant’s amendments to independent claim 52 requiring the preserving composition comprised within the kit to consist of a cholesterol: cyclodextrin complex (CC complex), a biological buffer, a cryoprotectant, a carbohydrate, and a cell permeable anti-oxidant peptide, wherein the CC complex comprises cholesterol and methyl β-cyclodextrin at a weight ratio of about 90 mg cholesterol to about 1 g methyl β-cyclodextrin, obviate the rejection of record. It is of note that Applicant’s amendments have narrowed the claim scope through the transitional phrase, as well as introduced the new limitation of requiring a carbohydrate within the claimed preserving composition.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 52-55 and 69 under 35 USC 103 over Richard et al as evidenced by Dicker et al, in view of Shahverdi et al as evidenced by BioXcell®, and further in view of Dicker et al
The cancellation of claims 55 and 69 render the rejection of record moot for those claims. For the remaining claims, Applicant’s amendments to independent claim 52 requiring the preserving composition comprised within the kit to consist of a cholesterol: cyclodextrin complex (CC complex), a biological buffer, a cryoprotectant, a carbohydrate, and a cell permeable anti-oxidant peptide, wherein the CC complex comprises cholesterol and methyl β-cyclodextrin at a weight ratio of about 90 mg cholesterol to about 1 g methyl β-cyclodextrin, obviate the rejection of record. It is of note that Applicant’s amendments have narrowed the claim scope through the transitional phrase, as well as introduced the new limitation of requiring a carbohydrate within the claimed preserving composition.
Therefore, the rejection is withdrawn.
New Grounds of Rejection
Claim Objections
Claim 49 is objected to because of the following informalities:
Regarding claim 49: The instant claim is objected to for reciting “[t]he preserving composition of claim 37, for preserving ejaculate and/or isolated sperm” instead of “[t]he preserving composition of claim 37, wherein the preserving composition is formulated for the preservation of .
Appropriate correction is required.
Claim Interpretation
The instant Specification defines the term “about” to mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. These terms of degree should be construed as including a deviation of at least ±5% of the modified term if this deviation would not negate the meaning of the word it modifies. See Paragraph [0072] of the instant disclosure.
Instant claim 49 recites an intended use limitation. Intended use limitations are considered only
in so far that they impart structural limitations to the claimed composition. In the instant case, the intended use of “preserving ejaculate and/or isolated sperm” does not structurally alter the preserving composition. Therefore, the preserving composition of claim 37 will inherently read on the limitation of instant claim 49, as the preserving composition is physically capable of being utilized for the preservation of ejaculate and/or isolated sperm.
Likewise, instant claims 50-51, 68, and 70 recite intended use limitations. In the instant case, the intended use of combining an individual dosage of the preserving composition with a defined dosage or volume of sperm/semen does not structurally alter the preserving composition itself – especially considering the instantly claimed preserving composition is restricted to the five-component formulation. Therefore, so long as the preserving composition is provided in an individual dosage, it is physically capable of being combined with the listed volume of sperm/semen and thereby reads on the limitations of the instant claims. See MPEP § 211.04(II).
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 37, 39-43, 49-54, 67-68, and 70-73 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 37, 39-43, 49-51, 67-68, and 70-71: Independent claim 37 is directed to a preserving composition consisting of a cholesterol: cyclodextrin (CC complex), a biological buffer, a cryoprotectant, a carbohydrate, and a cell permeable anti-oxidant peptide, wherein the CC complex comprises cholesterol and methyl β-cyclodextrin at a weight ratio of about 90 mg cholesterol to about 1 g methyl β-cyclodextrin (emphasis added).
The further limiting of closed claim language – “the preserving composition consisting of… and” – using open language – “comprises” – renders the scope of the claim indefinite, as the ordinary artisan cannot readily determine the metes and bounds of the claim.
Instant claims 39-43, 49-51, 67-68, and 70-71 are included within the rejection because they depend from a rejected claim. However, it is of note that instant claim 71 is further rejected under 35 USC 112(b), as it also further limits the closed claim language recited in independent claim 37 using open language.
Appropriate correction is required.
Regarding claims 52-54 and 72: Independent claim 52 is directed to a kit comprising, in part, a preserving composition consisting of a cholesterol: cyclodextrin (CC complex), a biological buffer, a cryoprotectant, a carbohydrate, and a cell permeable anti-oxidant peptide, wherein the CC complex comprises cholesterol and methyl β-cyclodextrin at a weight ratio of about 90 mg cholesterol to about 1 g methyl β-cyclodextrin (emphasis added).
The further limiting of closed claim language – “the preserving composition consisting of… and” – using open language – “comprises” – renders the scope of the claim indefinite, as the ordinary artisan cannot readily determine the metes and bounds of the claim.
Instant claims 53-54 and 72 are included within the rejection because they depend from a rejected claim. However, it is of note that instant claim 72 is further rejected under 35 USC 112(b), as is also further limits the closed claim language recited in independent claim 52 using open language.
Appropriate correction is required.
Regarding claim 73: Independent claim 73 is directed to a preserving composition consisting of a cholesterol: cyclodextrin (CC complex), a biological buffer, a cryoprotectant, a carbohydrate, and a cell permeable anti-oxidant peptide, wherein the CC complex comprises cholesterol and methyl β-cyclodextrin at a weight ratio of about 90 mg cholesterol to about 1 g methyl β-cyclodextrin, the biological buffer comprises about 3% w/v tris and about 1.8% w/v citric acid monohydrate, the carbohydrate is about 1.2% w/v fructose, the cryoprotectant is about 7% v/v glycerol, and the cell permeable anti-oxidant peptide is SS31 at about 20 μM or mTP4 at about 20 μM (emphasis added).
The further limiting of closed claim language – “the preserving composition consisting of… and” – using open language – “comprises” – renders the scope of the claim indefinite, as the ordinary artisan cannot readily determine the metes and bounds of the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 37, 39, 41-43, 49-53, 67-68, and 70-72 are rejected under 35 U.S.C. 103 as being unpatentable over Ostermeier et al (US 2013/0189669 A1) in view of Loskutoff et al (US 2003/0186212 A1).
Ostermeier et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2). Loskutoff et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 37: Ostermeier et al disclose methods for sperm cryoprotection and compositions comprising a cryoprotectant, a membrane protectant that stabilizes or assists in the stabilization of membranes of sperm, and a free radical scavenger (Abstract).
As such, Ostermeier et al disclose a cryopreservation media consisting of a membrane protectant, a biological buffer, a cryoprotectant, a carbohydrate, and an antioxidant (Paragraphs [0004], [0007]-[0008], [0017]-[0019], [0039]-[0051]).
Ostermeier et al further disclose that the membrane protectant comprises animal- or plant-derived cholesterol (Paragraph [0043]).
Ostermeier et al do not disclose that the membrane protectant is a cholesterol: cyclodextrin complex having cholesterol and methyl β-cyclodextrin at a weight ratio of about 90 mg cholesterol to about 1 g methyl β-cyclodextrin, as required by instant claim 37.
Loskutoff et al, however, disclose cryogenic solutions for the preservation of sperm comprising a cholesterol: cyclodextrin complex (CC complex), which is utilized to stabilize the membrane of the sperm cells (Abstract; Paragraphs [0031], [0044], [0059]). Loskutoff et al further disclose through an incorporated reference that the cyclodextrin within the CC complex is methyl β-cyclodextrin, and is at a weight ratio of 30 mg cholesterol to 1 g methyl β-cyclodextrin (Paragraph [0044]; Page 13786 of Klein et al).
Therefore, it would have been prima facie obvious to have substituted the cholesterol membrane protectant of Ostermeier et al with the cholesterol: methyl β-cyclodextrin complex of Loskutoff et al, as doing do would have been a simple substitution of one cholesterol-based membrane protectant for another. See MPEP § 2143(I)(B). One of ordinary skill before the effective filing date of the invention would have recognized that the two cholesterol-based membrane protectants are functionally comparable, as they both stabilize and protect sperm membranes, and thereby would have been able to substitute the two cholesterol-based membrane protectants with predictable results.
Consequently, Ostermeier et al as modified by Loskutoff et al render obvious a cryopreservation media consisting of a membrane protectant, a biological buffer, a cryoprotectant, a carbohydrate, and an antioxidant, wherein the membrane protectant is a cholesterol: methyl β-cyclodextrin complex having a weight ratio of 30 mg cholesterol to 1 g methyl β-cyclodextrin. As 30 mg cholesterol reads on “about 90 mg cholesterol” given the Claim Interpretation section above, this therefore renders obvious the preserving composition of the instant claim. See MPEP § 2144.05.
Regarding claim 39: Following the discussion of claim 37, Ostermeier et al further disclose that the cryoprotectant is glycerol (Paragraphs [0008], [0024], [0041], [0048]). This therefore reads on the preserving composition of the instant claim.
Regarding claims 41 and 67: Following the discussion of claim 37, Loskutoff et al further disclose that the CC complex is at a concentration of 0.01 to 2.5 mg/mL (Paragraphs [0044], [0059]). This therefore renders obvious the preserving composition of instant claims 41 and 67 for the same reasons as discussed in the rejection of instant claim 37. See MPEP § 2131.03 and 2144.05.
Regarding claims 42-43: Following the discussion of claim 37, Loskutoff et al further disclose through the incorporated reference that the cholesterol can be stigmasterol (claim 43) (Paragraph [0044]; Page 13786 of Klein et al). This therefore renders obvious the preserving composition of instant claims 42 for the same reasons as discussed in the rejection of instant claim 37.
Regarding claims 49-51, 68, and 70: Following the discussion of claim 37, Ostermeier et al further disclose that the cryopreservation media is provided within individual samples and mixed with semen samples (Paragraphs [0057], [0077], [0104]-[0105]). Given the Claim Interpretation section above, this therefore reads on the preserving composition of the instant claims 49-51 and 70, since the cryopreservation media is physically capable of being combined with defined volumes of semen.
Regarding claim 52: As aforementioned in the discussion of claim 37, Ostermeier et al as modified by Loskutoff et al render obvious a cryopreservation media consisting of a membrane protectant, a biological buffer, a cryoprotectant, a carbohydrate, and an antioxidant, wherein the membrane protectant is a cholesterol: methyl β-cyclodextrin complex having a weight ratio of about 90 mg cholesterol to 1 g methyl β-cyclodextrin.
Ostermeier et al further disclose a kit comprising the cryopreservation media and straws for packaging ejaculate (Paragraphs [0058]-[0070]).
This therefore renders obvious the kit of the instant claim for the same reasons as discussed in the rejection of instant claim 37.
Regarding claim 53: Following the discussion of claim 52, Ostermeier et al further disclose that the cryoprotectant is glycerol (Paragraphs [0008], [0024], [0041], [0048]). This therefore reads on the kit of the instant claim.
Regarding claims 71-72: Following the discussion of claim 37 and 52, Ostermeier et al further disclose that the glycerol is at 12% v/v, which reads on “about 7% v/v” (Paragraph [0104]). This therefore reads on the preserving composition (claim 71) and kit (claim 72) of the instant claims.
Claims 37, 39-43, 49-54, 67-68, and 70-73 are rejected under 35 U.S.C. 103 as being unpatentable over Ostermeier et al (US 2013/0189669 A1) in view of Loskutoff et al (US 2003/0186212 A1), and further in view of Dicker et al (WO 2011/108946 A1, of record).
The discussion of Ostermeier et al as modified by Loskutoff et al regarding claims 37 and 52 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Ostermeier et al as modified by Loskutoff et al render obvious claims 37, 39, 41-43, 49-53, 67-68, and 70-72. Dicker et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claims 40 and 54: As aforementioned in the discussion of claims 37 and 52, Ostermeier et al as modified by Loskutoff et al render obvious a cryopreservation media consisting of a membrane protectant, a biological buffer, a cryoprotectant, a carbohydrate, and an antioxidant.
The combination of Ostermeier et al and Loskutoff et al fail to teach that the antioxidant is SS31 or mTP4, as required by instant claims 40 and 54.
Dicker et al, however, disclose methods for improving the functionality and/or fertility of sperm, such methods comprising contacting semen and/or sperm with an effective amount of a composition comprising a mitochondria targeted antioxidant (Abstract). As such, Dicker et al disclose that the antioxidant comprised within the composition is SS31 (H-D-Arg-Dmt-Lys-Phe-NH2), which is a peptide-based mitochondria targeted antioxidant (Pages 10-11). Dicker discloses the compositions comprising sperm and antioxidant can be cryopreserved (Pages 6-7; Page 23, Example 6).
Therefore, it would have been prima facie obvious to have substituted the antioxidant within the cryopreservation media of Ostermeier et al as modified by Loskutoff et al with the SS31 antioxidant of Dicker et al, as doing so would have been a simple substitution of one antioxidant for another. See MPEP § 2143(I)(B). One of ordinary skill before the effective filing date of the invention would have recognized that the two antioxidants are functionally comparable, as both are capable of reducing the oxidative damage to sperm cells comprised within a sample, and would have thereby been able to substitute the antioxidants with predictable results.
Consequently, Ostermeier et al as modified by Loskutoff et al and Dicker et al render obvious a cryopreservation media consisting of a membrane protectant, a biological buffer, a cryoprotectant, a carbohydrate, and an antioxidant, wherein the antioxidant is SS31. This therefore renders obvious the preserving composition (claim 40) and kit (claim 54) of the instant claims.
Regarding claim 73: As aforementioned in the discussion of claim 40, Ostermeier et al as modified by Loskutoff et al and Dicker et al render obvious a cryopreservation media consisting of a membrane protectant, a biological buffer, a cryoprotectant, a carbohydrate, and an antioxidant, wherein the membrane protectant is a cholesterol: methyl β-cyclodextrin complex having a weight ratio of about 90 mg cholesterol to 1 g methyl β-cyclodextrin, and wherein the antioxidant is SS31.
Loskutoff et al further disclose a Tris base solution consisting of 2.42% tris, 1.38% citric acid, 1.00% fructose, and 6.14% glycerol (Paragraph [0040]).
Dicker et al further disclose through an incorporated reference that the SS31 is comprised within a buffer solution at a concentration of about 10 μM (Pages 10-11; US 2009/0221514 A1, Paragraph [0213]).
Therefore, Ostermeier et al as modified by Loskutoff et al and Dicker et al render obvious a cryopreservation media consisting of a membrane protectant, a biological buffer, a cryoprotectant, a carbohydrate, and an antioxidant, wherein the membrane protectant is a cholesterol: methyl β-cyclodextrin complex having a weight ratio of about 90 mg cholesterol to 1 g methyl β-cyclodextrin, the biological buffer is 2.42% tris and 1.38% citric acid, the carbohydrate is 1.00% fructose, the cryoprotectant is 6.14% glycerol, and the antioxidant is about 10 μM SS31. This thereby renders obvious the preserving composition of the instant claim for the same reasons as discussed in the rejection of claims 37 and 40. See MPEP § 2131.03 and 2144.05.
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 ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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