DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
1. Formal Matters
A. In the response dated 8/20/25, Applicants elected the species of modulating eotaxin-1. However, upon further review, all claims have been examined.
B. Claims 1-21 are pending and are the subject of this Office Action.
2. Specification
A. If applicable, the first line of the specification should be updated to reflect the status (e.g. “now U.S. Patent No.”, or “now abandoned”) of any parent applications. Similarly, though none could be found, any U.S. or Foreign Applications cited in the specification which have since issued should be updated with the corresponding Patent No.
B. Though none could be found, any listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
C. Though no issues could be found, Applicant is advised that embedded hyperlinks and/or other forms of browser-executable code are impermissible and require deletion. The attempt to incorporate subject matter into the patent application by reference to a hyperlink and/or other forms of browser-executable code is considered to be an improper incorporation by reference. See MPEP 608.01(p), paragraph I regarding incorporation by reference. It is noted that the recitation of “www.” alone, as opposed to “http://www.”, is also active and should not be used.
D. Though no issues could be found, trade names or marks used in commerce should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
E. Though no issues could be found, when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, the sequence must still be included in the Sequence Listing and a sequence identifier ("SEQ ID NO:X") must be used either in the drawing or in the Brief Description of the Drawings. See MPEP § 2422.02.
F. Though no issues could be found, according to 37 CFR 1.821(d) (MPEP § 2422), where the description or claims of a patent application discuss a sequence listing that is set forth in the "Sequence Listing" in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the assigned identifier, in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.
G. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
3. Claim Rejections - 35 USC § 112(a) – scope of enablement
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for reducing CCL11-induced neurogenesis, does not reasonably provide enablement for treating (1) any and all aging-associated impairments (2) by modulating (i.e. increasing) CCR3 or (3) by reducing anything other than CCL11 levels or (4) for preventing any aging-associated impairment. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The breadth of the claims is excessive with regard to claiming methods of treating adult mammals for any and all aging-associated impairments. Applicants have identified elevated levels of CCL11 in old unpaired and young heterochronic mice (see, for example, the first full paragraph on page 59 of the specification). In the following paragraph, Applicants further state that they have identified systemic factors associated with aging and decreased neurogenesis and have shown that CCL11 administration causes a decrease in Dcx promoter-dependent luciferase activity, which they associate with decreased neurogenesis (page 60, lines 6-11). Applicants also conclude (sentence bridging pages 61-62) that increased CCL11 levels impair hippocampal-dependent learning and memory.
Therefore, while Applicants provide guidance and working examples that CCL3 can decrease neurogenesis and impair hippocampal-dependent learning and memory, the specification does not need to provide any such guidance or working examples that neurogenesis, learning and memory, or any other aging-associated impairment can be treated. At most, respectfully, it is shown that anti-CCL11 antibodies can reduce or, at most, neutralize CCL11-related decrease in neurogenesis. Given only this minimal guidance and working examples, it is not predictable to one of ordinary skill in the art how to treat any and all aging-associated impairment, as this term encompasses anything from the neurological examples, to a decrease in muscle mass, reduced vision and hearing, reduced energy, pain (e.g. arthritis), osteoporosis and a host of other aging-associated impairments.
Furthermore, the specification only appears to provide guidance and working examples that decreasing CCL11 levels would have any potential effect. However, the claims (e.g. claim 1) recite “modulating”, which encompass increasing the levels of CCL11 (or its binding to CCR3). Increasing CCL11 would be expected to over-activate CCR3, thereby causing an increase in its activity, which would be expected, given Applicants’ guidance and examples, to be undesirable. Similarly, claim 10 recites reducing CCR3 levels; however, it is not clear if the interaction of CCL11 is solely via CCR3. Therefore, it is not predictable that reducing CCR3, itself, would act as desired.
In addition, the Examiner has interpreted the term “prevention” as a condition (impairment) will not occur in 100% of the population administered the compound. Applicants have not provided any guidance or working examples that any administered compound/treatment would have such an effect, nor, given this, would it have been predictable that 100% of a population administered any compound would be prevented from any and all aging-associated impairments.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
4. Nonstatury Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A. Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,912,998 (17/550,787). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to identical methods. The only essential difference is that the patent is drawn to treatment, wherein the instant claims are drawn to prevention.
B. Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,236,340 (16/842,054). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to identical methods. The only essential difference is that the patent is drawn to neurogenesis, wherein the instant claims are generic. Furthermore, the patent is drawn to treatment, wherein the instant claims are drawn to prevention.
Instant claims 1-18 are met by patent claims 1-18, respectively. Instant claims 19 and 20 are met by patent claim 19. The species of patent claims 1 and 20-25 anticipate generic claim 1 of the instant application.
C. Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,626,399 (16/067,771). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to identical methods. The only essential difference is that the patent is drawn to a cognitive impairment, wherein the instant claims are generic (aging-associated). Furthermore, the patent is drawn to treatment, wherein the instant claims are drawn to prevention.
Instant claims 1-18 are met by patent claims 1-18, respectively. Instant claims 19 and 20 are met by patent claim 19. The species of patent claims 1 and 20-24 anticipate generic claim 1 of the instant application.
It is noted that patent claim 20 lacks antecedent basis for “the elderly mammal”. However, given the context of “aging-associated”, it can be inferred that some of the mammals would be elderly.
6. 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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
A. Claims 1, 2, 10-14, 19 and 21 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Takeda et al. (cited on page 12 of 14 on the 1449 submitted 2/26/24). Takeda teaches administration of CCR3 ligand to mice (page 227, right column, first full paragraph). Though Takeda does not teach aging-associated impairment, the administration of the ligands of Takeda would inherently prevent impairment. Case law has established that a compound and all of its properties are inseparable, as are its processes and yields (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)).
It is also noted that the teachings of Takeda are drawn to “age-related macular degeneration”, which occurs in older populations. Regarding claim 19, Takeda is silent with regard to elderly. However, absent evidence to the contrary, as well as the absence of a definition in the specification, it is expected that the animals tested by Takeda would include elderly.
B. Claims 1, 2, 10, 11, 15, 16, 19 and 21 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Fortin et al. Fortin teaches administration of antisense oligodeoxynucleotides targeting CCR3 in rats (Title; Abstract). Though Fortin does not teach aging-associated impairment, the administration of the ligands of Fortin would inherently prevent impairment (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)). The decrease in CCR3 meets claims 2 and 10.
Regarding claim 19, Fortin is silent with regard to elderly. However, absent evidence to the contrary, as well as the absence of a definition in the specification, it is expected that the animals tested by Fortin would include elderly.
7. Conclusion
No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647