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 .
DETAILED ACTION
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 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.
Response to Amendments
Applicant’s amendments, corrected specification, IDS, and response filed May 15, 2025 have been received and entered into the case.
Status of the Claims
Claims 1, 3-7 and 25-47 are currently pending.
Claim 1 is amended.
Claims 3-7 and 25-41 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 2 and 8-24 are cancelled.
Claim 42-47 are new.
Claims 1 and 42-47 have been considered on the merits.
Specification Objections
The specification objections are withdrawn due to amendment.
Claim Objections
The claim objections are withdrawn due to amendment.
Claim Rejections - 35 USC § 112 (a)
The claim rejections under 35 USC § 112, (a) or first paragraph (pre-AIA ), for written description and scope of enablement are withdrawn due to amendment.
Claim Rejections - 35 USC § 102
The claim rejections under 35 USC § 102 are withdrawn due to amendment. New claim rejections under 35 USC § 102 have been added to address the claim amendments.
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 and 44-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mossanen et al. (Gastroenterology, 2019) (ref. of record).
With respect to claims 1 and 44-46, Mossanen teaches a method of reducing the number of senescent cells in the liver (a selected target organ) of a mouse by administering a therapeutically effective amount of α-galactosylceramide (α-GalCer) to activate invariant natural killer T (iNKT) cells (abstract and pg. 1878 Col. 2 para. 3 and pg. 1884 Col. 2 para. 2-3, and Fig. 6). Mossanen further teaches a method of reducing the number of senescent cells in the liver (a selected target organ) (abstract).
It is noted that Mossanen does not teach that their method can be used in the manner instantly claimed for reducing the number of senescent cells in a selected target tissue, organ or compartment selected from the group of adipose tissue, the lung, the kidney, the spleen, the brain, cardiovascular tissue, the pancreas, skeletal muscle or the dermis as recited in claim 1, where the selected target tissue, organ or compartment is adipose tissue as recited in claim 44, or where the selected target tissue, organ or compartment is the lung as recited in claim 45. However, Mossanen teach the claimed method of administering a therapeutically effective amount of α-GalCer to a subject. Once administered to the subject the α-GalCer would reduce senescent cells in all tissues, organ or compartments of the subject. Thus, the claimed result of reducing the number of senescent cells in adipose tissue, the lung, the kidney, the spleen, the brain, cardiovascular tissue, the pancreas, skeletal muscle and the dermis of the subject must be inherent to the method as taught by Mossanen and a necessary effect of practicing the method. Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims."
Therefore, the reference anticipates the claimed subject matter.
Claims 1 and 42-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Donda et al. (WO 2008/103392 A1) (ref. of record).
With respect to claims 1 and 42, Donda teaches a method of modulating an immune response by administering to an animal a therapeutically effective amount of a composition containing an antigen-loaded soluble CD1d molecule that affects the activity of CD1d-restricted NKT cells (0067-0068, 0195 and 0218). Donda teaches alpha-galactosylceramide (α-GalCer) is complexed with a CD1d protein (0044-0045 and 0068). With respect to claim 43, Donda teaches the complex containing CD1d dimers, trimers and tetramers (0075). With respect to claim 46, Donda teaches the subject is a non-human animal (0231 and 0234). With respect to claim 47, Donda teaches the subject is a human subject (0231 and 0234).
It is noted that Donda does not teach that their method can be used in the manner instantly claimed for reducing the number of senescent cells in a selected target tissue, organ or compartment selected from the group of adipose tissue, the lung, the kidney, the spleen, the brain, cardiovascular tissue, the pancreas, skeletal muscle or the dermis as recited in claim 1, where the selected target tissue, organ or compartment is adipose tissue as recited in claim 44, or where the selected target tissue, organ or compartment is the lung as recited in claim 45. However, Donda teach the claimed method of administering a therapeutically effective amount of α-GalCer to a subject. Once administered to the subject the α-GalCer would reduce senescent cells in all tissues, organ or compartments of the subject. Thus, the claimed result of reducing the number of senescent cells in adipose tissue, the lung, the kidney, the spleen, the brain, cardiovascular tissue, the pancreas, skeletal muscle and the dermis of the subject must be inherent to the method as taught by Donda and a necessary effect of practicing the method. Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims."
Therefore, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
The claim rejections under 35 USC § 103 are withdrawn due to amendment. New claim rejections under 35 USC § 103 have been added to address the claim amendments.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1 and 42-47 are rejected under 35 U.S.C. 103 as being unpatentable over Mossanen et al. (Gastroenterology, 2019) (ref. of record) in view of Donda et al. (WO 2008/103392 A1) (ref. of record).
With respect to claims 1 and 44-46, Mossanen teaches a method of reducing the number of senescent cells in the liver (a selected target organ) of a mouse by administering a therapeutically effective amount of α-galactosylceramide (α-GalCer) to activate invariant natural killer T (iNKT) cells (abstract and pg. 1878 Col. 2 para. 3 and pg. 1884 Col. 2 para. 2-3, and Fig. 6). Mossanen further teaches a method of reducing the number of senescent cells in the liver (a selected target organ) (abstract).
It is noted that Mossanen does not teach that their method can be used in the manner instantly claimed for reducing the number of senescent cells in a selected target tissue, organ or compartment selected from the group of adipose tissue, the lung, the kidney, the spleen, the brain, cardiovascular tissue, the pancreas, skeletal muscle or the dermis as recited in claim 1, where the selected target tissue, organ or compartment is adipose tissue as recited in claim 44, or where the selected target tissue, organ or compartment is the lung as recited in claim 45. However, Mossanen teach the claimed method of administering a therapeutically effective amount of α-GalCer to a subject. Once administered to the subject the α-GalCer would reduce senescent cells in all tissues, organ or compartments of the subject. Thus, the claimed result of reducing the number of senescent cells in adipose tissue, the lung, the kidney, the spleen, the brain, cardiovascular tissue, the pancreas, skeletal muscle and the dermis of the subject must be inherent to the method as taught by Mossanen and a necessary effect of practicing the method. Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims."
Mossanen does not teach the method where the α-GalCer is complexed with a CD1 d protein or oligomer as recited in claim 42 or where the α-GalCer is complexed with a CD1 d dimer or tetramer as recited in claim 43.
However, Donda teaches a similar method of activating NKT cells in a subject for therapeutic purposes by administering to an animal a therapeutically effective amount of a composition containing an antigen-loaded soluble CD1d molecule that affects the activity of CD1d-restricted NKT cells (0067-0068, 0195 and 0218). Donda teaches the method where α-GalCer is complexed with a CD1d protein (0044-0045 and 0068). Donda further teaches the complex containing CD1d dimers, trimers and tetramers (0075). Donda teaches the composition allows for multiple administrations without causing CD1d-restricted NKT cell anergy in response to an antigen or prevents the NKT cells from becoming non-responsive (abstract and 0199).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Mossanen so that the α-GalCer is complexed with a CD1d protein or oligomer including a dimer or tetramer for the benefit of preventing NKT cell anergy in response to the α-GalCer antigen as taught by Donda. Furthermore, it would have been obvious to one skilled in the art to have further modified Mossanen such that the α-GalCer is complexed with a CD1d protein or oligomer including a dimer or tetramer, since similar methods of administering such compositions to subjects to activate NKT cells were known as taught by Donda. Such a modification involves the substitution of one known variant of α-GalCer for another for activating iNKT cells in vivo. For these reasons one of ordinary skill in the art would have a reasonable expectation of success in making such a modification to Mossanen.
Mossanen does not teach the method where the subject is human.
However, Donda teaches a similar method of activating NKT cells in a subject for therapeutic purposes by administering to an animal a therapeutically effective amount of a composition containing an antigen-loaded soluble CD1d molecule that affects the activity of CD1d-restricted NKT cells (0067-0068, 0195 and 0218). Donda teaches the method where the subject is a human subject (0231 and 0234).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Mossanen so that the subject is human for the benefit of treating additional subjects as taught by Donda. Furthermore, it would have been obvious to one skilled in the art to have further modified Mossanen such that the subject is human, since similar methods of administering such compositions to human subjects to activate NKT cells were known as taught by Donda. Such a modification involves the substitution of one known subject for another for activating iNKT cells in vivo. For these reasons one of ordinary skill in the art would have a reasonable expectation of success in making such a modification to Mossanen.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed May 15, 2025 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 102, Applicant argues that Mossanen does not disclose administering α-GalCer to reduce senescent cells in adipose tissue, the lung, the kidney, the spleen, the brain, cardiovascular tissue, the pancreas, skeletal muscle or the dermis (Remarks pg. 13 para. 3). The Applicant’s amendments limiting claim 1 necessitated the withdrawal of previous rejections. Applicant’s arguments are drawn to Mossanen failing to teach this new limitation. However, this new limitation is addressed in the new rejection. Specifically, since Mossanen teaches the claimed method of administering a therapeutically effective amount of α-GalCer to a subject. Once administered to the subject the α-GalCer would reduce senescent cells in all tissues, organ or compartments of the subject. Thus, the claimed result of reducing the number of senescent cells in adipose tissue, the lung, the kidney, the spleen, the brain, cardiovascular tissue, the pancreas, skeletal muscle and the dermis of the subject must be inherent to the method as taught by Mossanen and a necessary effect of practicing the method.
Applicant argues that Teyton does not teach administering α-GalCer or a variant thereof to reduce senescent cells and the reduction of senescent cells is not inherent to the method of Teyton (Remarks pg. 13 para. 4). Applicants arguments with respect to Teyton were consider, but are moot since Teyton is no longer a reference being used in the current set of rejections.
Applicant argues that Truneh does not teach administering α-GalCer or a variant thereof to reduce senescent cells and is only concerned with antibodies that bind iNKT cells and uses α-GalCer-loaded CD1 tetramers to identify iNKT cells and the reduction of senescent cells is not inherent to the method of Truneh (Remarks pg. 13-14 bridging para.). Applicants arguments with respect to Truneh were consider, but are moot since Truneh is no longer a reference being used in the current set of rejections.
With respect to the rejections under 35 U.S.C. § 103, Applicant argues that the rationale that it would be obvious to substitute one type of iNKT activator for another is inapplicable, since the claim is now limited to α-GalCer or a variant thereof and the question is whether Mossanen can be combined with either Teyton or Truneh (Remarks pg. 14 para. 6). The Applicant’s amendments limiting claim 1 necessitated the withdrawal of previous rejections. Applicant’s arguments are drawn to Mossanen in combination with Teyton or Truneh not teaching the new limitations. However, the new limitations are addressed in the new rejection and Teyton and Truneh are no longer references used in the current set of rejections.
Applicant argues that Mossanen does not disclose administering α-GalCer or a variant thereof to reduce senescent cells in any of the tissues recited. Applicant argues that Teyton does not disclose reducing senescent cells in any tissues, and is instead focused on bacterial burden in the lungs. Applicant argues that there is no motivation in Teyton that would lead one of ordinary skill to apply Mossanen’s method to any of the claimed tissues (Remarks pg. 14-15 bridging para.). The Applicant’s amendments limiting claim 1 necessitated the withdrawal of previous rejections. Applicant’s arguments are drawn to Mossanen failing to teach this new limitation. However, this new limitation is addressed in the new rejection. Specifically, since Mossanen teaches the claimed method of administering a therapeutically effective amount of α-GalCer to a subject. Once administered to the subject the α-GalCer would reduce senescent cells in all tissues, organ or compartments of the subject. Thus, the claimed result of reducing the number of senescent cells in adipose tissue, the lung, the kidney, the spleen, the brain, cardiovascular tissue, the pancreas, skeletal muscle and the dermis of the subject must be inherent to the method as taught by Mossanen and a necessary effect of practicing the method. Applicants arguments with respect to Teyton were consider, but are moot since Teyton is no longer a reference being used in the current set of rejections.
Applicant argues that Truneh does not disclose reducing senescent cells in any tissues, and is instead focused on airway hyper-responsiveness (AHR) which is a pathological affect (Remarks pg. 15 para. 2). Applicants arguments with respect to Truneh were consider, but are moot since Truneh is no longer a reference being used in the current set of rejections.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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