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
Election/Restrictions
Applicant’s election without traverse of the invention, Group I, in the reply filed on 03/02/2026 is acknowledged.
Claims 156, 160, 163, 167, 169, 172, 177, 179, 181, 184, 192 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/02/2026.
Claims 1, 125, 141-144, 147-148 are under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/01/2023, 01/27/2025, 03/02/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because of the following:
FIG. 4A: Change “Neutalization” to “Neutralization” on the Y-axis.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pages 55, 62, 63, 65. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the term BIACORE® (p. 59-60), which is a trade name or a mark used in commerce, has been noted in this application. The term 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.
Claim Objections
Claim 125 is objected to because of the following informalities:
Claim 125: Insert a “a” between “comprises” and “heavy”, for example, “comprises a heavy”.
Appropriate correction is required.
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 144 and 147 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a human metapneumovirus (hMPV) infection or detecting human metapneumovirus (hMPV), does not reasonably provide enablement for (1) preventing or treating just any virus infection or detecting just any virus (as recited in claim 144 “a virus”) and (2) preventing a viral infection, such as human metapneumovirus infection, with the antibody or antigen binding fragment of claim 1 (see also 35 U.S.C. 112(b) rejection below). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Here, claim 144 is drawn a pharmaceutical composition for preventing, treating, or detecting a virus comprising: the antibody or antigen binding fragment of claim 1; and a pharmaceutically acceptable carrier. Additionally, claim 147 is drawn to a kit for preventing, treating, or detecting hMPV comprising: the antibody or antigen binding fragment thereof of claim1; and instruction for use.
For claim 144, the specification does not discuss preventing, treating, or detecting “a virus” other than human metapneumovirus.
For claims 144 and 147, the specification defines the terms “prevent” or “preventing” as “means to administer a prophylactic agent, such as a composition containing any of the polypeptides of the present invention, to a subject or patient at risk of becoming infected by human metapneumovirus (hMPV). Preventing includes reducing the likelihood or severity of a subsequent hMPV infection, ameliorating symptoms associated with a subsequent hMPV infection, and inducing immunity to protect against hMPV infection. Typically, the agent is administered in an amount effective to neutralize hMPV in the body in order to block infection” (p. 66-67). The instant application invention elected does not include “polypeptides”.
The level of skill in the art is high and would include, e.g., Ph.D. level scientists, physicians.
The state of the prior art:
Shafagati et al. (Shafagati)(2018) evidences the following:
- “Similar to other respiratory pathogens, HMPV causes most severe disease in infants and young children, the elderly, and persons with underlying chronic conditions such as asthma, emphysema, and immune compromise”(p. 4).
- “Humans and animals mount neutralizing antibody responses to HMPV”(p. 5).
- “HMPV, like other respiratory viruses, dampens the immune response after infection, but the specific mechanisms remain unclear”(p. 5).
-“Treatment consists of supportive care as there are no licensed antivirals against HMPV…Two potential treatments that have been investigated are ribavirin and immunoglobulin…[Ribavirin] is a nucleoside with activity against RNA viruses and exhibits in vitro activity against HMPV and exhibited some efficacy in mice…Commercial intravenous immunoglobulin (IVIG) contains neutralizing activity against HMPV, and as noted above, antibodies alone exhibit efficacy both prophylactically and therapeutically in mice…There are anecdotal reports of human use of ribavirin and IVIG but no controlled trials and no guidelines to recommend the use of these measures”(p. 6).
- “There are currently no licensed vaccines for HMPV, but numerous efforts have been made to develop a safe and effective vaccine”(p. 6).
More recently, Principi et al. (Principi)(2025) evidences that “no vaccine or antiviral agent is currently approved for the prevention or treatment of HMPV infection. Several vaccine candidates—especially subunit and mRNA vaccines—have shown acceptable safety and immunogenicity in adults, and some are approaching phase 3 readiness. However, clinical data in children, especially infants and seronegative populations, remain limited or absent. Given the risk of vaccine-associated enhanced disease (VAED), particularly in immunologically naïve infants, careful evaluation of safety and efficacy in this group is imperative”(p. , Conclusions).
The specification only exemplifies neutralization. The specification offers no working examples or direction for preventing human metapneumovirus infection. In view of the foregoing, a vast quantity of experimentation, including extensive animal and clinical trials, would be required to use the invention as a pharmaceutical composition (as recited in claim 144) or as part of a kit (as recited in claim 147) based on the content of the disclosure.
Taken together, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with the claims. To overcome this rejection, specify the virus, e.g., human metapneumovirus (hMPV), and remove “preventing”.
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 144, 147 and 148 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.
Claims 144 and 147: The phrase “preventing, treating or detecting a virus/hMPV” is unclear. One doesn’t treat (or prevent) a virus (or hMPV). More accurately, one treats (or prevents) a viral (or hMPV) infection. However, one does, though, detect a virus/hMPV.
Claim 148: The language “a polynucleotide encoding the amino acid sequences of any one of the antibody or antigen binding fragments thereof of claim 1” lacks antecedent basis and is unclear. Claim 1 recites only an antibody or antigen binding fragment comprising the stated six CDR sequences. To overcome rejection, correct to “a polynucleotide encoding the amino acid sequences of the antibody or antigen binding fragment thereof of claim 1”.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 143 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 143 recites “a cell transformed with an expression vector of claim 142”. The “a cell” reads on a human organism. To overcome the rejection, change to “isolated cell”.
Allowable Subject Matter
Claims 1, 141, and 142 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Cornelius whose telephone number is (571) 272-0860. The examiner can normally be reached M-F, 0930-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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