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 . 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.
Priority
The instant application is a 371 of PCT/EP2020/074046 filed on 08/28/2020 and claims foreign priority to European application no. EP19193982.6 filed on 08/28/2019. The certified copy of the foreign priority application filed on 02/18/2022 in the instant application is acknowledged.
Status of the Claims
The claim amendments and remarks filed on 08/22/2025 is acknowledged. Claims 1-2, 9-11, 13-14, and 21 are amended. Claims 4-6 and 15-16 are cancelled.
Accordingly, claims 1-3, 7-14, and 17-21 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 112(a) rejection over claims 11 and 14 are withdrawn in view of the removal of the term “prevent” and “preventing” in the claims.
The 35 USC 112(a) rejection over claims 1-14 and 17-21 are withdrawn in view of amended claims 1 and 21 now reciting a new Formula (I) structure that has a +5 oxidation state on the phosphorous groups instead of a +6 oxidation state.
The 35 USC 112(b) rejection over claims 9, 14, and 17 are withdrawn in view of amended claim 1 now reciting a new Formula (I) structure that has a +5 oxidation state on the phosphorous groups instead of a +6 oxidation state, which properly encompasses the recited compounds in claims 9 and 17. Additionally, the removal of the thiophosphate compounds corrects the antecedent basis issue as the new Formula (I) structure does not recite a thiophosphate, and the amendment of “active agent” from “pharmaceutical active ingredient” corrects the antecedent basis issue .
Specification
The disclosure is objected to because of the following informalities:
The recited formula on page 5 and page 8 shows the Formula (I) structure having phosphorous groups at a +6 oxidation state rather than the +5 oxidation state as amended in the claims. Therefore, the recited formulas on page 5 and page 8 should be fixed accordingly.
Appropriate correction is required.
Claim Objections
Claims 1 and 21 are objected to because of the following informalities:
The recited formula (I) structure in claims 1 and 21 has poor resolution and lacks clarity of the bonds shown in the structure.
Appropriate correction is required.
New Rejections Necessitated by the Amendments filed on 08/22/2025
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.
Claim 8 is 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.
Claim 8 recites “… wherein in the compound according to formula (I) R3 is a OH group, X is an oxygen atom …”.
Claim 8 is indefinite because formula (I) contains multiple R3 and X groups and recites “X is independently from one another … R3 is independently from one another …”, making it unclear if all R3 and all X must be OH group and oxygen atom, respectively, or if just one of R3 and one of X needs to be OH group and oxygen atom, respectively.
For purposes of examination, claim 8 is being interpreted as all R3 and all X must be OH group and oxygen atom, respectively.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 7-8, 10-14, and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Borriello et al. (Frontiers in Immunology, 2017 in PTO-892) and as evidenced by Kranzusch et al. (Molecular cell, 2015 in PTO-892).
Borriello teaches the use of STING ligands and their formulations for enhancement of early life immunization (see second paragraph right column page 2). Borriello teaches that vaccines often demonstrate reduced efficacy in newborns and young infants compared to adults due to age-specific immunity (see Abstract). Borriello teaches that newborn innate immune cells exhibit distinct activation profiles in response to pattern recognition receptor (PRR) agonists and only certain PRR agonists or their combinations are able to induce an adult-like response (see left column first paragraph page 2). Borriello teaches that neonatal CD4+ T cells produce lower amounts of IFN-gamma and are skewed toward Th2, Th17, and Treg polarization (see left column first paragraph page 2). Borriello further teaches that adjuvants exhibit age-specific patterns of Th-polarization such that adjuvantation systems that boost adult immune responses do not necessarily lead to enhanced vaccine efficacy in newborns or young infants (see left column first paragraph page 2). Therefore, Borriello teaches that identification of vaccine adjuvants capable of activating neonatal and infant immune responses may inform development of adjuvanted vaccine formulations that enhance early life immunization (see left column first paragraph page 2).
Borriello identified 2’3’-cGAMP (cGAMP) as an adjuvant candidate for early life immunization from a screening test of PRR agonists (see Abstract and Figure 1 on page 6). Borriello teaches that cGAMP induces a comparable expression of surface maturation markers in newborn and adult bone marrow derived dendritic cells (BMDCs) (see Abstract and first paragraph left column on page 5).
Here, as evidenced by Kranzusch on Figure 2E, 2’3’-cGAMP meets the limitation of an adjuvant according to the recited formula (I) in claims 1 and 21 as shown below:
PNG
media_image1.png
329
433
media_image1.png
Greyscale
As shown above, cGAMP contains an adenine residue recited in claim 7, as well as wherein R3 is a OH group, X is an oxygen atom, and Y, Y’, Z, and Z’ are oxygen recited in claim 8. Furthermore, since the Z and Z’ groups respectively form a covalent bond to one of the two R3 positions, the R3 group with the covalent bond at its respective position is absent as recited in claims 1 and 21. Additionally, the lefthand nucleobase of cGAMP meets the limitation of the bottom left nucleobase in the recited formula when R2 and R4 are H and R1 is NH2. The right nucleobase of cGAMP meets the limitation of the top right nucleobase in the recited formula when R4 is H, R2 is O, and R1 is NH2.
Borriello utilized the trivalent recombinant hemagglutinin (rHA) influenza vaccine, Flubock, as a model antigen to investigate the role of cGAMP in adult and early life immunization (see Abstract). Borriello demonstrates that Flublok immunization formulated with both cGAMP and alum (Alhydrogel) enhanced rHA-specific IgG2a/c titers ~400 fold in newborn mice, which is an antibody subclass associated with the development of IFN gamma-driven type 1 immunity in vivo and endowed with higher effector functions, by 42 days of life (see Abstract and Figure 2 on page 7). Borriello teaches that both nenonate and adult mice were immunized by intramuscular injection to the right posterior thigh (see last paragraph left column on page 3). Borriello concludes that cGAMP when formulated with alum may represent an effective adjuvantation system to foster humoral and cellular aspects of type 1 immunity for early life immunization (see Abstract).
In regards to instant claim 21, the recited kit merely serves as a support and does not have a functional relationship to the recited formulation. Therefore, the recited kit is owed no patentable weight, and the recited formulation is anticipated as discussed above. MPEP 2111.05 recites “"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." and MPEP 2111.05 I. B recites “Where a product merely serves as a support for printed matter, no functional relationship exists.”
Therefore, claims 1-2, 7-8, 10-14, and 19-21 are anticipated.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 7-14, 17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Borriello et al. (Frontiers in Immunology, 2017 in PTO-892).
The teachings of Borriello are as discussed above and teach the method recited in claims 1-2, 7-8, 10-14, and 19-20 and the formulation recited in claim 21 as described above.
Furthermore, Borriello teaches that dendritic cells (DCs) play a pivotal role in activating T cells and instructing the adaptive immune response (see second paragraph left column page 2). Borriello teaches these cells express a high diversity of PRRs, whose activation leads to DC migration to lymph nodes and enhancement of immune-stimulatory functions (see second paragraph left column page 2). Borriello teaches that a systems vaccinology analysis of young infants vaccinated with trivalent inactivated influenza vaccine with or without the oil-in-water adjuvant MF59 demonstrated that innate immune gene signatures (e.g., antiviral and DC genes) 1-day post-immunization correlated with vaccine efficacy, highlighting the importance of robust innate immune activation in early life immunization (see second paragraph left column page 2). Borriello teaches that agonists of the intracellular receptors TLR7/8, that recognize viral single-stranded RNAs, potently activate Th1-polarizing responses, including expression of interferons (IFNs), production of IL-12p70 and upregulation of co-stimulatory molecules in newborn DCs in vitro and enhance vaccine efficacy in newborn non-human primates in vivo (see second paragraph left column page 2). Moreover, Borriello teaches that adjuvantation with the TLR9 agonist CpG increases CG Tfh and B cell responses in newborn mice (see second paragraph left column page 2)
Borriello teaches that among intra-cellular PRRs, the stimulator of interferon genes (STING) is an amenable target for adjuvant discovery and development (see second paragraph left column page 2). Borriello teaches that it binds cyclic dinucleotides (CDNs) derived from bacteria (i.e., c-di-AMP, c-di-GMP, and 3′3′-cGAMP) or synthesized in mammalian cells by cGAMP synthase in response to double-stranded DNA in the cytoplasm (i.e., 2′3′-cGAMP) (see second paragraph left column page 2 through first paragraph right column page 2). Here, as evidenced by the instant specification on page 6 line 5, the c-di-AMP disclosed in Borriello is also to referred to as CDA.
Borriello teaches that upon activation, STING induces the TBK-1-mediated phosphorylation of IRF3, which in turn modulates the expression of type I IFNs, IFN stimulated genes, and also promotes DC maturation and type 1 (i.e., IFNγ-driven) immunity (see first paragraph right column page 2). Accordingly, Borriello teaches that STING agonists have demonstrated promising adjuvanticity in adult experimental models of parenteral and mucosal immunization as well as cancer immunotherapy (first paragraph right column page 2).
Even though Borriello does not demonstrate the use of CDA as an adjuvant in their study, it would have been prima facie obvious to substitute cGAMP with c-di-AMP as disclosed in Borriello to arrive at the claimed invention. One of ordinary skill in the art would have made this substitution with a reasonable expectation of success because Borriello provides guidance that cyclic dinucleotides including c-di-AMP and cGAMP are all STING agonists that induce immune responses and demonstrates the use of a STING agonist as an adjuvant for early life immunization. Therefore, an ordinary skilled artisan could have predictably considered using alternative STING agonists for the cGAMP and would have a reasonable expectation of success that these alternative STING agonists such as c-di-AMP would result in the same enhanced adjuvant effect in early life as demonstrated by Borriello.
Claim(s) 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Borriello et al. (Frontiers in Immunology, 2017 in PTO-892), as applied to claim 1 above, and further in view of Madhun et al. (Vaccine, 2011 in PTO-892).
The teachings of Borriello are as discussed above and teach the method of claim 1 as described above.
The difference between Borriello and the claimed invention is that Borriello does not teach wherein the compound is administered as a mucosal adjuvant.
Madhun teaches intranasal c-di-GMP-adjuvanted plant-derived H5 influenza vaccine that induces multifunctional Th1 CD4+ cells and strong mucosal and systemic antibody responses in mice (see Abstract). Madhun demonstrates in Fig. 2 on page 4975 that intranasal administration of c-di-GMP-adjuvanted vaccine enhanced immune response whereas intramuscular administration did not. Madhun teaches that the intranasal vaccine also elicited a balanced Th1/Th2 profile (see Abstract), and further teaches that a needle-free intranasal influenza vaccine is an attractive approach, which is easy to administer, likely to have high public compliance, and optimal for mass vaccination (see right column page 4973).
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the method of Borriello by administering their vaccine formulation intranasally as disclosed in Madhun to arrive at the claimed invention. One of ordinary skill in art would have been motivated to make this modification with a reasonable expectation of success because Madhun demonstrates that a similar c-di-GMP adjuvanted influenza vaccine that was administered via intranasal had several advantages including enhanced immune response and balanced Th1/Th2 profiles, and provides further guidance that a needle-free intranasal influenza vaccine is an attractive approach, which is easy to administer, likely to have high public compliance, and optimal for mass vaccination. Therefore, an ordinary skilled artisan would have a motivation to administer the vaccine formulation disclosed in Borriello via intranasal administration in order to obtain the described advantages in Madhun.
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.
Claim 1-3, 7-14, and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,881,726 (‘726) in view of Borriello et al. (Frontiers in Immunology, 2017 in PTO-892).
Claim 1 of ‘726 recites an immunogenic composition comprising a) a hepatitis C virus (HCV) E1 polypeptide, an HCV E2 polypeptide, or an HCV E1/E2 heterodimer; and b) a cyclic dinucleotide (CDN). Claim 5 of ‘726 recites that the CDN is c-diGMP, c-diAMP, c-dilMP, c-dXMP, c-GpAp, c-Gplp, c-GpXp, c-Aplp, c-ApXp, or c-lpXp. Claims 11-12 of ‘762 recites a method of inducing an immune response to HCV in an individual, the method comprising administering an effective amount of the recited immunogenic composition, and further recites that the administering is via intramuscular or intranasal administration.
The difference between the claims of ‘726 and the claimed invention is that the claims of ‘726 do not recite administering to an individual that is an unborn child, a neonate, or an infant.
The teachings of Borriello are as described above.
It would have been prima facie obvious to combine the claims of ‘726 and Borriello before the effective filing date of the claimed invention by modifying the method recited in the claims of ‘726 to administer to a neonate as disclosed in Borriello. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Borriello provides guidance that the same CDN compounds enhanced early life immunization in similar vaccine-based compositions. Therefore, an ordinary skilled artisan could have chosen from a finite number of predictable outcomes such as administering to a neonate with a reasonable expectation of success.
In regards to instant claim 21, the recited kit merely serves as a support and does not have a functional relationship to the recited formulation. Therefore, the recited kit is owed no patentable weight, and the claims of ‘726 recite the same formulation as discussed above. MPEP 2111.05 recites “"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." And MPEP 2111.05 I. B recites “Where a product merely serves as a support for printed matter, no functional relationship exists.”
Claim 1-3, 7-14, and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,576,968 (‘968) in view of Borriello et al. (Frontiers in Immunology, 2017 in PTO-892).
Claim 1 of ‘968 recites a method of inducing an immune response to an antigen in an individual, the method comprising administering to the individual: a) one or more nucleic acids comprising nucleotide sequences encoding a hepatitis C virus (HCV) E1 polypeptide, an HCV E2 polypeptide, or an HCV E1/E2 heterodimer; and b) a cyclic dinucleotide (CDN). Claim 5 of ‘968 recites that the CDN is c-diGMP, c-diAMP, c-dilMP, c-dXMP, c-GpAp, c-Gplp, c-GpXp, c-Aplp, c-ApXp, or c-lpXp. Claims 12 of ‘968 recites that the administering is via intramuscular or intranasal administration.
The difference between the claims of ‘968 and the claimed invention is that the claims of ‘968 do not recite administering to an individual that is an unborn child, a neonate, or an infant.
The teachings of Borriello are as described above.
It would have been prima facie obvious to combine the claims of ‘968 and Borriello before the effective filing date of the claimed invention by modifying the method recited in the claims of ‘968 to administer to a neonate as disclosed in Borriello. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Borriello provides guidance that the same CDN compounds enhanced early life immunization in similar vaccine-based compositions. Therefore, an ordinary skilled artisan could have chosen from a finite number of predictable outcomes such as administering to a neonate with a reasonable expectation of success.
In regards to instant claim 21, the recited kit merely serves as a support and does not have a functional relationship to the recited formulation. Therefore, the recited kit is owed no patentable weight, and the claims of ‘968 recite the same formulation as discussed above. MPEP 2111.05 recites “"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." And MPEP 2111.05 I. B recites “Where a product merely serves as a support for printed matter, no functional relationship exists.”
Claim 1-3, 7-14, and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,042,536 (‘536) in view of Borriello et al. (Frontiers in Immunology, 2017 in PTO-892).
Claim 1 of ‘536 recites an immunogenic composition comprising a) a cyclic dinucleotide (CDN); and b) a hepatitis C virus (HCV) E1/E2 heterodimer; and c) a heterologous polypeptide comprising a T-cell epitope present in an HCV protein other than E1 and E2. Claim 5 of ‘726 recites that the CDN is c-diGMP, c-diAMP, c-dilMP, c-dXMP, c-GpAp, c-Gplp, c-GpXp, c-Aplp, c-ApXp, or c-lpXp. Claims 11-12 of ‘762 recites a method of inducing an immune response to HCV in an individual, the method comprising administering an effective amount of the recited immunogenic composition, and further recites that the administering is via intramuscular or intranasal administration.
The difference between the claims of ‘536 and the claimed invention is that the claims of ‘536 do not recite administering to an individual that is an unborn child, a neonate, or an infant.
The teachings of Borriello are as described above.
It would have been prima facie obvious to combine the claims of ‘536 and Borriello before the effective filing date of the claimed invention by modifying the method recited in the claims of ‘536 to administer to a neonate as disclosed in Borriello. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Borriello provides guidance that the same CDN compounds enhanced early life immunization in similar vaccine-based compositions. Therefore, an ordinary skilled artisan could have chosen from a finite number of predictable outcomes such as administering to a neonate with a reasonable expectation of success.
In regards to instant claim 21, the recited kit merely serves as a support and does not have a functional relationship to the recited formulation. Therefore, the recited kit is owed no patentable weight, and the claims of ‘536 recite the same formulation as discussed above. MPEP 2111.05 recites “"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." And MPEP 2111.05 I. B recites “Where a product merely serves as a support for printed matter, no functional relationship exists.”
Claim 1-3, 7-14, and 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,597,391 (‘391) in view of Borriello et al. (Frontiers in Immunology, 2017 in PTO-892).
Claim 1 of ‘391 recites a method of enhancing an immune response in a subject in need thereof for eliciting a balanced Th1/Th2 response, comprising the step of administering, as an adjuvant with one or more different antigens, to the subject at least one compound according to the recited formula (I). Claim 4 of ‘391 recites that the compound according to formula (I) is a cyclic bis(3′-5′)diadenylic acid. Claims 8 and 10 of ‘381 recite that the adjuvant is administered by either intranasal or intramuscular administration.
The difference between the claims of ‘391 and the claimed invention is that the claims of ‘391 do not recite administering to an individual that is an unborn child, a neonate, or an infant.
The teachings of Borriello are as described above.
It would have been prima facie obvious to combine the claims of ‘391 and Borriello before the effective filing date of the claimed invention by modifying the method recited in the claims of ‘391 to administer to a neonate as disclosed in Borriello. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Borriello provides guidance that the same CDN compounds enhanced early life immunization in similar vaccine-based compositions. Therefore, an ordinary skilled artisan could have chosen from a finite number of predictable outcomes such as administering to a neonate with a reasonable expectation of success.
In regards to instant claim 21, the recited kit merely serves as a support and does not have a functional relationship to the recited formulation. Therefore, the recited kit is owed no patentable weight, and the claims of ‘391 recite the same formulation as discussed above. MPEP 2111.05 recites “"[O]nce it is determined that the limitation is directed to printed matter, [the examiner] must then determine if the matter is functionally or structurally related to the associated physical substrate, and only if the answer is ‘no’ is the printed matter owed no patentable weight." And MPEP 2111.05 I. B recites “Where a product merely serves as a support for printed matter, no functional relationship exists.”
Conclusion
No claim is found allowable.
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 DAVID H CHO whose telephone number is (571)270-0691. The examiner can normally be reached M-F 8AM-5PM.
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, Scarlett Goon can be reached at 571-270-5241. 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.
/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693