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 Application, Amendments, And/Or Claims
The Applicants amendments/remarks received 9/16/2025 are acknowledged. Claims 1, 5, 21 and 23 are amended; claims 2-4, 8-20 and 29 are canceled; no claims are withdrawn; claims 1, 5-7 and 21-28 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statement submitted on 9/16/2025 has been considered by the examiner.
Response to Amendment - format of claims
The amendment to the claims filed on 9/16/2025 does not comply with the requirements of 37 CFR 1.121(c) because amended claims 21 and 23 list the claim status as “(Presently Amended)” which is not a status identifier listed in 37 CFR 1.121(c). Claims 21 and 23 should have the status identifier “(Currently amended)”. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number. (emphasis added).
Because claims 21 and 23 are obviously “(Currently Amended)”, a Notice of Non-Compliant Amendment has not been sent, and the claims have been examined on the merits.
Response to Amendment
The declaration under 37 CFR 1.132 filed 9/16/2025 by inventor Suresh Mittal is insufficient to overcome the rejection of claims 1, 5-7 and 21-29 under 35 U.S.C. 112(a) for constituting new matter; the rejection of claims 5-7 and 21-29 under 35 U.S.C. 112(a) for lack of enablement or the rejection of claims 1, 5-7 and 21-29 under 35 U.S.C. 112(b) for indefiniteness as set forth in the last Office action because: The declaration does not point out where the alleged new matter is disclosed in the original disclosure, does not establish the enablement of the claims nor resolve the indefiniteness of the claims.
It is noted that opinion evidence as to a legal conclusion is not entitled to any weight and an affidavit of an applicant as to the advantages of their claimed invention is less persuasive than that of a disinterested person (MPEP 716.01(c)(III)). Declarant alleges that “First, a person of ordinary skill in the art would understand that the administration of a dosage of H1N1 or H3N2 would be in an amount necessary only to cause an asymptomatic infection. He or she would further know that a low dose resulting in 103 PFUs would not lead to detectable infectious virus shedding through intra-nasal administration. This was demonstrated in NHP models. See Marriot et al., Influenza A Virus Challenge Models in Cynomolgus Macaques Using the Authentic Inhaled Aerosol and Intra-Nasal Routes of Infection, DOI:10.1371/journal.pone.0157887 Further, a person of ordinary skill recognizes PFU s as a dosage amount.
This comports with the disclosed studies in the patent application. For example, in paragraph [0076], it is disclosed that "Human PBMCs from 10 healthy subjects were isolated by using Vacutainer CPT™ Mononuclear Cell Preparation Tubes (BO Bioscience, San Jose, CA) according to the manufacturer's recommendations" and "cells were incubated with A/Taiwan/1/86 (H1N1) or A/HK/68 (H3N2) at an MOI of 3 PFU per cell for 16 hours or HAd-ΔE1E3 at an MOI of 10 PFU per cell for 16 hours."” (Declaration, ¶12-13).
The original disclosure does not recite, suggest or imply therapeutic compositions comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and an asymptomatic amount of H1N1 or H3N2 influenza virus nor does the original disclosure disclose what therapeutically effective amounts of such a therapeutic composition would be.
It appears that declarant may be arguing that therapeutic compositions, and their effective amounts, comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and an asymptomatic amount of H1N1 or H3N2 influenza virus are well-known in the art; hence, they do not have to be explicitly disclosed; however, Applicant does not point to any prior art administering a therapeutic composition comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and an asymptomatic amount of H1N1 or H3N2 influenza virus. Applicant has supplied Han et al., 2019, “A Dose-finding Study of a Wild-type Influenza A(H3N2) Virus in a Healthy Volunteer Human Challenge Model” (NPL cite 3, IDS, 9/16/2025) on the IDS accompanying the response and declaration, presumably as support for asymptomatic H3N2 virus infections. Han discloses that even at the lowest doses tested (104 TCID50 (50% tissue culture infectious dose)) four out of four human subjects had symptoms; 73% of subjects overall had symptoms; and no dosage level in the study had no symptoms among all subjects (Table 2). Hence, it is completely unclear what an asymptomatic dose of H3N2 influenza virus to a human subject would comprise. Neither the original disclosure, inventor’s declaration nor any prior art presented by Applicant or identified by the Examiner discloses the metes and bounds of a range of H1N1 or H3N2 influenza virus to administer to a human which would always result in an asymptomatic infection. Additionally, the declaration does not point to where the original disclosure discloses a therapeutic composition comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and an asymptomatic amount of H1N1 or H3N2 influenza virus (because no such composition is produced, described, suggested or implied by the original disclosure), nor to where the original disclosure discloses administering such a therapeutic composition comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and an asymptomatic amount of H1N1 or H3N2 influenza virus (because the original disclosure does not disclose any such administration), nor does the original disclosure recite or discuss an asymptomatic amount of H1N1 or H3N2 influenza virus, nor does the original disclosure recite or discuss what the metes and bounds of an asymptomatic amount of H1N1 or H3N2 influenza virus would comprise for a human subject. Inventor Mittal’s declaration asserts that all of these limitations would be obvious over the prior art, yet fails to provide prior art which would confirm the suggestion that the administration of an asymptomatic amount of H1N1 or H3N2 influenza virus is well-known in the art. The declaration does not make up for the deficiencies of the original disclosure and the rejection under 35 U.S.C. 112(a) for lack of written description by constituting new matter is maintained.
Applicant alludes to the in vitro tissue culture infection of peripheral blood mononuclear cells (PBMC) with EITHER nonreplicating human adenovirus type C5 having E1 and E3 deletions OR H1N1 or H3N2 influenza virus (Declaration, ¶13). There is no nexus between this in vitro tissue culture infection of cells with virus to determine the induction of ILCs AND any therapeutic composition comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and an asymptomatic amount of H1N1 or H3N2 influenza virus: No asymptomatic amount of H1N1 or H3N2 influenza virus is disclosed in the original disclosure; the concept of an asymptomatic amount of H1N1 or H3N2 influenza virus is not disclosed, suggested or implied anywhere in the original disclosure; and no compositions comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions AND an asymptomatic amount of H1N1 or H3N2 influenza virus are disclosed, discussed, suggested or implied in the original disclosure. The in vitro experiment alluded to by inventor does not determine what amount of H1N1 or H3N2 influenza virus would be asymptomatic nor does the in vitro experiment administer nonreplicating human adenovirus type C5 having E1 and E3 deletions AND an asymptomatic amount of H1N1 or H3N2 influenza virus; hence, there is no nexus between the tissue culture experiment alluded to by inventor and any composition comprising an asymptomatic amount of H1N1 or H3N2 influenza virus or any composition comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions AND an asymptomatic amount of H1N1 or H3N2 influenza virus; hence, the declaration does not make up for the deficiencies of the original disclosure and the rejection under 35 U.S.C. 112(a) for lack of written description by constituting new matter is maintained.
The declaration does not disclose how a method infecting subjects with H1N1 or H3N2 is enabled for a protecting a subject against a respiratory viral infection when the method is giving the subject a respiratory viral infection, asymptomatic or not, because the method itself involves infecting the human subject with a viral respiratory agent. Hence, the rejection under 35 U.S.C. 112(a) for lack of enablement is maintained.
Finally, the declaration does not resolve the indefiniteness for any of the claims rejected under 35 U.S.C. 112(b) as being indefinite; hence, the rejection under 35 U.S.C. 112(b) as being indefinite is maintained.
Claim Objections
The objection to claims 1 and 5, as set forth at pp. 4-5 of the previous Office Action is withdrawn in view of the amendment of the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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, 5-7 and 21-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The original disclosure does not disclose therapeutically effective amounts of compositions comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and influenza virus (H1N1 or H3N2), whether an asymptomatic amount of influenza virus or otherwise. The original disclosure does not disclose administering compositions comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and influenza virus (H1N1 or H3N2) whether an asymptomatic amount or otherwise, to any subject for any reason nor does the original disclosure disclose any therapeutic effect from the administering of said composition. Hence, claim 1 constitutes new matter.
Additionally, amended claim 1 recites administering an asymptomatic amount of H1N1 or H3N2 influenza virus which constitutes new matter. The original disclosure does not recite administering an asymptomatic amount of H1N1 or H3N2 influenza virus alone or with nonreplicating human adenovirus type C5 having E1 and E3 deletions; hence, the recitation of “an asymptomatic amount of H1N1 or H3N2 influenza virus” additionally constitutes new matter.
Claims 5-7 and 21-29 depend from claim 1 and also constitute the new matter of claim 1. Thus, claims 1, 5-7 and 21-28 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement for constituting new matter.
Additionally, the original disclosure does not disclose that administering therapeutically effective amounts of compositions comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and influenza virus (H1N1 or H3N2) is sufficient to cause a sustained intracellular accumulation of CD 103+ dendritic cells (DCs) in infected cells after 14 days post administration nor is it disclosed that DC cells accumulate inside infected cells at any time point with any administration; hence, claim 23 constitutes new matter separate and in addition to the new matter introduced into claim 1.
Additionally, the original disclosure does not disclose the therapeutically effective amount is administered in a 10:3 ratio of nonreplicating human adenovirus type C5 having E1 and E3 deletions to influenza virus (H1N1 or H3N2); hence, claim 29 constitutes new matter separate and in addition to the new matter introduced into claim 1.
Additionally, the original disclosure does not disclose the therapeutically effective amount is measurable, at least in part, as a ratio of nonreplicating human adenovirus type C5 having E1 and E3 deletions and influenza virus (H1N1 or H3N2) at a multiplicity of infection (MOI) of about 10 plaque forming units (PFU) per cell in sample human PBMCs for nonreplicating human adenovirus type C5 having E1 and E3 deletions to about 3 PFU per cell for influenza virus (H1N1 or H3N2); hence, claim 21 constitutes new matter separate and in addition to the new matter introduced into claim 1.
Response to Arguments
Applicant's arguments filed 9/16/2025 have been fully considered but they are not persuasive. Regarding the rejection of claims 1, 5-7 and 21-29 under 35 U.S.C. §112(a) (Written Description), Applicant (pp. 5-6) points the Mittal declaration, which has been discussed on pp. 4-8 above. Applicant further points to the in vitro tissue culture experiment in [0076] of the original disclosure. The in vitro tissue culture infection of peripheral blood mononuclear cells (PBMC) with EITHER nonreplicating human adenovirus type C5 having E1 and E3 deletions OR H1N1 or H3N2 influenza virus (Declaration, ¶13). Applicant does not provide any nexus between this in vitro tissue culture infection of cells with virus to determine the induction of ILCs AND any therapeutic composition comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and an asymptomatic amount of H1N1 or H3N2 influenza virus: No asymptomatic amount of H1N1 or H3N2 influenza virus is disclosed in the original disclosure; the concept of an asymptomatic amount of H1N1 or H3N2 influenza virus is not disclosed, suggested or implied anywhere in the original disclosure; and no compositions comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions AND an asymptomatic amount of H1N1 or H3N2 influenza virus are disclosed, discussed, suggested or implied in the original disclosure. The in vitro experiment pointed to by Applicant does not determine what amount of H1N1 or H3N2 influenza virus would be asymptomatic nor does the in vitro experiment administer nonreplicating human adenovirus type C5 having E1 and E3 deletions AND an asymptomatic amount of H1N1 or H3N2 influenza virus; hence, there is no nexus between the tissue culture experiment pointed to by Applicant and any composition comprising an asymptomatic amount of H1N1 or H3N2 influenza virus or any composition comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions AND an asymptomatic amount of H1N1 or H3N2 influenza virus; hence, Applicant does not explain or make up for the deficiencies of the original disclosure and the rejection under 35 U.S.C. 112(a) for lack of written description by constituting new matter is maintained.
Claims 5-7 and 21-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 5 recites the method of claim 1, wherein the patient is a human subject; thus, even though claim 1 does not recite a patient, it is interpreted that claim 5 and dependent claims 6-7 and 21-24 are drawn to the method of claim 1 wherein human subjects are administered a composition comprising influenza virus wherein the influenza virus is H1N1 (swine flu) or H3N2 (often called Hong Kong flu).
An estimated 201200 respiratory deaths and 83300 cardiovascular deaths were associated with 2009 pandemic influenza A H1N1 (Daweed, 2009; NPL cite 1, IDS, 2/22/2023); hence, purposely infecting a human subject with influenza virus, especially H1N1, would appear to NOT enable claim 1 for its purported provision of immune protection against a respiratory viral infection. Instead, the method itself is infecting the human subject with a respiratory viral agent. Hence, while the method might possibly be effective for inducing activation of ILCs in the subject, it is clearly NOT enabled for preventing respiratory viral infections because the method itself involves infecting the human subject with a viral respiratory agent. Claims 6-7 and 21-24 depend from claim 5; thus, claims 6-7 and 21-24 also lack enablement and are rejected under 35 U.S.C. 112(a).
Response to Arguments
Regarding the rejection of claims 1, 5-7 and 21-29 under 35 U.S.C. 112(a) for lack of enablement, Applicant argues (Remarks, p. 7) “The claims have been amended to recite that the dosage of, e.g., HlNi would be an "asymptomatic" dose, which is identified in the specification as about "3 PFU per cell for influenza virus" (See, e.g., [0076]; see also, Mittal Declaration at ¶ 12 and Exhibit B, p 3.)” This is incorrect. 3 PFU per cell for influenza virus is NOT identified in the specification as an asymptomatic dose, at [0076] or anywhere else in the original disclosure. The original disclosure does not identify any dosage of influenza virus as an asymptomatic dose, nor does the original disclosure teach, suggest or imply administering an asymptomatic dose of influenza virus to any subject, with or without a nonreplicating human adenovirus type C5 having E1 and E3 deletions; hence, Applicant’s arguments are completely unpersuasive.
As discussed above, the in vitro tissue culture infection of peripheral blood mononuclear cells (PBMC) infects the cells with EITHER nonreplicating human adenovirus type C5 having E1 and E3 deletions OR H1N1 or H3N2 influenza virus [0076]. Applicant does not provide any nexus between this in vitro tissue culture infection of cells with virus to determine the induction of ILCs AND any therapeutic composition comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions and an asymptomatic amount of H1N1 or H3N2 influenza virus: No asymptomatic amount of H1N1 or H3N2 influenza virus is disclosed in the original disclosure; the concept of an asymptomatic amount of H1N1 or H3N2 influenza virus is not disclosed, suggested or implied anywhere in the original disclosure; and no compositions comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions AND an asymptomatic amount of H1N1 or H3N2 influenza virus are disclosed, discussed, suggested or implied in the original disclosure. The in vitro experiment pointed to by Applicant does not determine what amount of H1N1 or H3N2 influenza virus would be asymptomatic nor does the in vitro experiment administer nonreplicating human adenovirus type C5 having E1 and E3 deletions AND an asymptomatic amount of H1N1 or H3N2 influenza virus; hence, there is no nexus between the tissue culture experiment pointed to by Applicant and any composition comprising an asymptomatic amount of H1N1 or H3N2 influenza virus or any composition comprising nonreplicating human adenovirus type C5 having E1 and E3 deletions AND an asymptomatic amount of H1N1 or H3N2 influenza virus; hence, Applicant pointing to the in vitro tissue culture experiment at [0076] does not explain or make up for the deficiencies of the original disclosure and the rejection under 35 U.S.C. 112(a) for lack of enablement is maintained.
Infecting a subject with a respiratory viral agent, such as an asymptomatic amount of H1N1 or H3N2, is giving a subject a respiratory viral infection regardless of whether the respiratory viral infection is asymptomatic; hence, the conclusion that the method is not enabled for protecting the subject against a respiratory viral infection is maintained.
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, 5-7 and 21-28 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 claim 1, the claim is indefinite because the claim recites a method step of “administering” a therapeutically effective amount of HAdΔE1E3 non-replicating adenovirus and H1N1 or H3N2 influenza virus, but who or what the composition is administered to is unclear. Neither the preamble nor the body of the claim identifies who or what is to be administered the composition; hence, claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite. Claims 5-7 and 21-28 depend from claim 1 and do not resolve the indefiniteness; hence, claims 1, 5-7 and 21-28 are rejected under 35 U.S.C. 112(b) as being indefinite.
Additionally, claim 1 recites “an asymptomatic amount of H1N1 or H3N2 influenza virus”. Neither the claims nor the specification gives any indication to the metes and bounds of the limitation, i.e., there is no disclosure in the specification as to what the range of H1N1 or H3N2 influenza virus that would be encompassed by the term “an asymptomatic amount”; hence, the limitation is indefinite. Claims 5-7 and 21-28 depend from claim 1 and do not resolve the indefiniteness; hence, claims 1, 5-7 and 21-28 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 5 recites the limitation "the patient" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 5 depends from claim 1, but neither claim 1 nor claim 5 recite a patient; hence, claim 5 is rejected under 35 U.S.C. 112(b) as being indefinite. Claims 6-7 and 21-24 depend from claim 5 and do not resolve the indefiniteness; hence, claims 6-7 and 21-24 are also rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 5 recites the limitation "the activated ILCs" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 5 depends from claim 1. None of claims 1 or 5 recite activated ILCs; hence, claim 5 is rejected under 35 U.S.C. 112(b) as being indefinite. Claims 6-7 and 21-24 depend from claim 5 and do not resolve the indefiniteness; hence, claims 6-7 and 21-24 are also rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 6 recites the limitation "the pharmaceutically effective amount" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 6 depends from claim 5 which depends from claim 1. None of claims 1, 5 or 6 recite a pharmaceutically effective amount; hence, claim 6 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 7 recites the limitation "the lungs" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 7 depends from claim 5 which depends from claim 1. None of claims 1, 5 or 7 recite lungs; hence, claim 7 is rejected under 35 U.S.C. 112(b) as being indefinite. Claim 24 depends from claim 7 and does not resolve the indefiniteness; hence, claims 24 is also rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 28 recites the limitation "the pharmaceutically effective amount" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 28 depends from claim 1. None of claims 1 or 28 recite a pharmaceutically effective amount; hence, claim 28 is rejected under 35 U.S.C. 112(b) as being indefinite.
Regarding claim 21, the claim is indefinite because the claim recites “wherein the therapeutically effective amount of is measurable...”, wherein the preposition “of” has no object. Because it is unclear what the object of the preposition is, claim 21 is rejected under 35 U.S.C. 112(b) as being indefinite. Claims 22-23 depend from claim 21 and do not resolve the indefiniteness; hence, claims 21-23 are also rejected under 35 U.S.C. 112(b) as being indefinite.
Response to Arguments
Applicant has not presented any arguments regarding the rejection of claims 1, 5-7 and 21-29 under 35 U.S.C. 112(b) for being indefinite, nor have the claims been amended to address the rejections under 35 U.S.C. 112(b); hence, the rejections are maintained as well as new rejections for the indefiniteness introduced by the claim amendments are presented.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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, Melenie Gordon can be reached at 571-272-8037. 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.
/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651