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
Acknowledgement is hereby made of receipt and entry of the communication filed on May 10, 2023. Claims 1, 3, 5-8, 11, 13, 15-17, 19-20, 25, 28-35, 39-40, 43, 46-48, 50-51 and 53 are pending and currently examined.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 3, 5-8, 11, 13, 15-17, 19-20, 25, 28-35, 39-40, 43, 46-48, 50-51 and 53 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
These claims specify “wherein the at least one Lactobacillus reuteri strain comprises at least one sequence selected from SEQ ID NO: 1-55 and sequences having at least 98%, at least 98.5%, at least 99%, or at least 99.5% sequence identity with at least one of SEQ ID NO: 1-55”. This limitation renders to claims indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claims recite a broad range together with a narrow range in the same claim. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 20 depends from claim 18 which is canceled. Therefore, claim 20 is not clear. To facilitate examination, claim 20 is considered as if it depended from claim 17.
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 of this title, 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.
Claims 1, 3, 5, 7, 11, 13, 15, 16, 25, 28, 29, 32, 33, 47, 48 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Hibberd et al. (WO 2006/124630 A2, published on Nov. 23, 2006; submitted in IDS filed on Oct. 11, 2023) in view of WP_003670646.1 (aminotransferase [Limosilactobacillus reuteri]. Dated Oct. 11, 2019), Genbank: CP027805.1 (Limosilactobacillus reuteri strain WHH1689 chromosome, complete genome. Dated Apr. 26, 2018) and/or Wang et al. (CN 105219683 A, published on Jan. 6, 2016).
Base claims 1 and 29 are directed to a method of stimulating an immune response, increasing antibody titer to a vaccine in a subject, vaccinating a subject for an infectious respiratory disease, or decreasing viral load of an infectious respiratory disease virus in a subject, comprising: administering an effective amount of an immunogenic probiotic composition comprising at least one Lactobacillus reuteri strain and wherein the at least one Lactobacillus reuteri strain comprises at least one sequence selected from SEQ ID NO: 1-55 and sequences having at least 98%, at least 98.5%, at least 99%, or at least 99.5% sequence identity with at least one of SEQ ID NO: 1-55, and an infectious respiratory disease vaccine to a subject.
Base claim 47 is directed to an immunogenic probiotic composition, comprising: at least one Lactobacillus reuteri strain and wherein the at least one Lactobacillus reuteri strain comprises at least one sequence selected from SEQ ID NO:1-55 and sequences having at least 98%, at least 98.5%, at least 99%, or at least 99.5% sequence identity with at least one of SEQ ID NO:1-55, a pharmaceutically acceptable carrier, and an infectious respiratory disease vaccine.
Hibberd teaches an invention that includes compositions that include a probiotic and an immunogen (e.g., an influenza vaccine), kits that include these compositions, and methods of using the compositions and kits to treat a subject (e.g., a human subject). The composition can, for example, elicit an immune response against a virus that causes influenza. For example, the probiotic (e.g., Lactobacillus rhamnosus (LGG)) can serve as an adjuvant for a mucosally administered vaccine (e.g., a live attenuated influenza virus vaccine (LAIV) or an inactivated influenza vaccine (IN)). The adjuvant can be administered by any route (e.g., orally, mucosally, intramuscularly, subcutaneously, or intraperitoneally). These compositions (e.g., those containing an influenza vaccine and a probiotic) can be used to enhance the efficiency of an influenza vaccine (e.g., when administered to a subject). See Summary.
Hibberd further teaches that the compositions of the invention can include a probiotic microorganism such as a species of Lactobacillus. The probiotic microorganism can be one or a combination Lactobacillus species or strains, such as L. rhamnosus, L. acidophilus, L. casei, L. crispatus, L. bulgaricus, L. fermentum, L. jensenii, L. plantarum, L. reuteri, L. curvatus, L. salivarius, or L. johnsonii. See page 3, para 1.
Accordingly, Hibberd teaches an invention relating to a method of immunizing a subject comprising administrating to the subject a vaccine against influenza virus infection (which is a respiratory disease) and a probiotic microorganism as an adjuvant that enhances the vaccination effect. Hibberd teaches that the probiotic microorganisms can be Lactobacillus bacteria, including L. reuteri. However, Hibberd is silent on a Lactobacillus reuteri strain that comprises at least one sequence selected from SEQ ID NO:1-55 and sequences having at least 98%, at least 98.5%, at least 99%, or at least 99.5% sequence identity with at least one of SEQ ID NO:1-55.
WP_003670646.1 teaches the amino acid sequence of the aminotransferase of a Limosilactobacillus reuteri strain, which is 100% identical to the instant SEQ ID NO: 5. See alignment below:
SEQ1 1 MVEIAHFGVEAWLNKWEKSATYDISQSTIASLSMHDLLNLDGNNGEEFYEMLDKQQMNYG 60
MVEIAHFGVEAWLNKWEKSATYDISQSTIASLSMHDLLNLDGNNGEEFYEMLDKQQMNYG
WP_003 1 MVEIAHFGVEAWLNKWEKSATYDISQSTIASLSMHDLLNLDGNNGEEFYEMLDKQQMNYG 60
Query 61 WIEGSPEFKEEVAKLYHHVDPENILQTNGATGANILALYALINPGDHVIAEYPSYQQLYD 120
WIEGSPEFKEEVAKLYHHVDPENILQTNGATGANILALYALINPGDHVIAEYPSYQQLYD
Sbjct 61 WIEGSPEFKEEVAKLYHHVDPENILQTNGATGANILALYALINPGDHVIAEYPSYQQLYD 120
Query 121 IPKSLGADVDYWHIHEEDNWYPRIDDLKAMVKPNTKMICLNNANNPTGTVLDKEFLEQVV 180
IPKSLGADVDYWHIHEEDNWYPRIDDLKAMVKPNTKMICLNNANNPTGTVLDKEFLEQVV
Sbjct 121 IPKSLGADVDYWHIHEEDNWYPRIDDLKAMVKPNTKMICLNNANNPTGTVLDKEFLEQVV 180
Query 181 EIAKSVDAYVLVDEVYLPLDHPEKFAQIIDLYDKGISTNSLSKTYSVPGVRIGWTATNAE 240
EIAKSVDAYVLVDEVYLPLDHPEKFAQIIDLYDKGISTNSLSKTYSVPGVRIGWTATNAE
Sbjct 181 EIAKSVDAYVLVDEVYLPLDHPEKFAQIIDLYDKGISTNSLSKTYSVPGVRIGWTATNAE 240
Query 241 VADIFRKFRDYTMICGGVFNDQLATYVLRHRDQVLARNRKLVLGNLAIYKDWIDHEDRAS 300
VADIFRKFRDYTMICGGVFNDQLATYVLRHRDQVLARNRKLVLGNLAIYKDWIDHEDRAS
Sbjct 241 VADIFRKFRDYTMICGGVFNDQLATYVLRHRDQVLARNRKLVLGNLAIYKDWIDHEDRAS 300
Query 301 VIMPQAVSTSFPKLDVPVDIHTFCENLLHDEGVLLVPGDAFDTPGHVRLGYCAPEATLKE 360
VIMPQAVSTSFPKLDVPVDIHTFCENLLHDEGVLLVPGDAFDTPGHVRLGYCAPEATLKE
Sbjct 301 VIMPQAVSTSFPKLDVPVDIHTFCENLLHDEGVLLVPGDAFDTPGHVRLGYCAPEATLKE 360
Query 361 GLKRLSKYMHQYD 373
GLKRLSKYMHQYD
Sbjct 361 GLKRLSKYMHQYD 373
Accordingly, WP_003670646.1 discloses a Lactobacillus reuteri comprising an amino acid sequence of SEQ ID NO: 5.
Genbank: CP027805.1 discloses the complete genome sequence of Limosilactobacillus reuteri strain WHH1689, which comprises sequences that are identical to the instant SEQ ID NO: 28 or 29. See alignments below:
Alignment with SEQ ID NO: 28 (129nt):
Query Match 100.0%; Score 129; Length 2044184;
Best Local Similarity 100.0%;
Matches 129; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGGCTGGTATCAAAAGTATCGCAAAAGCGGTAATGACCCAGAATCACTTCGTGATCGCC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 190188 ATGGCTGGTATCAAAAGTATCGCAAAAGCGGTAATGACCCAGAATCACTTCGTGATCGCC 190247
Qy 61 GAGGCAAAGCTAAGCCAGAAGAGAAGTGGACGGAAGTTGACCGACTCAAGGCAGAAAATC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 190248 GAGGCAAAGCTAAGCCAGAAGAGAAGTGGACGGAAGTTGACCGACTCAAGGCAGAAAATC 190307
Qy 121 GCTTATTAA 129
|||||||||
Db 190308 GCTTATTAA 190316
Query Match 100.0%; Score 129; Length 2044184;
Best Local Similarity 100.0%;
Matches 129; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGGCTGGTATCAAAAGTATCGCAAAAGCGGTAATGACCCAGAATCACTTCGTGATCGCC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 518098 ATGGCTGGTATCAAAAGTATCGCAAAAGCGGTAATGACCCAGAATCACTTCGTGATCGCC 518039
Qy 61 GAGGCAAAGCTAAGCCAGAAGAGAAGTGGACGGAAGTTGACCGACTCAAGGCAGAAAATC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 518038 GAGGCAAAGCTAAGCCAGAAGAGAAGTGGACGGAAGTTGACCGACTCAAGGCAGAAAATC 517979
Qy 121 GCTTATTAA 129
|||||||||
Db 517978 GCTTATTAA 517970
Alignment with SEQ ID NO: 29 (117nt):
Query Match 100.0%; Score 117; Length 2044184;
Best Local Similarity 100.0%;
Matches 117; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGGCTAAATACACTGTTGAATTAAGTGAAGAAGATATCCAAATGATCAAGGATTGTCAT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1716266 ATGGCTAAATACACTGTTGAATTAAGTGAAGAAGATATCCAAATGATCAAGGATTGTCAT 1716207
Qy 61 TCAAAGAATCCTTCTATCATGAAGGCAATGAACGACGCTAAAAAAGTTGAAGATTAA 117
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1716206 TCAAAGAATCCTTCTATCATGAAGGCAATGAACGACGCTAAAAAAGTTGAAGATTAA 1716150
Wang teaches an invention relating to a Lactobacillus reuteri, strain LR1, deposited at China Microorganism Strain Preservation Management Committee Common Microorganism Centre as CGMCC No.11154. Wang teaches that the strain LR1 is isolated from intestinal tract of a healthy animal, having high safety, being resistant to high acid and gallbladder salt, and having inhibiting activity to common pathogenic bacteria in pigs, that it also can promote intestinal epithelial cell proliferation, promoting intestinal development mature animal, and that it also has immune regulation function. See Abstract.
Wang teaches that the LR1 strain comprises a 16s rDNA sequence (1427bp) comprising SEQ ID NO: 1 (see [0054-0055]). SEQ ID NO: 1 of Wang shares a common overlap or identity at 98.4% (506 matches, 8 mismatches) with instant SEQ ID NO. 25 (strain 3630) and at 99.4% (501 matches, 3 mismatches) with instant SEQ ID NO. 26 (strain 3632). Instant SEQ ID NO. 25 and 26 share a common overlap or identity at 99% (511 matches, 5 mismatches).
Accordingly, WP_003670646.1, Genbank: CP027805.1, and Wang each discloses a Lactobacillus reuteri comprising an amino acid sequence of SEQ ID NO: 5, or nucleotide sequence of SEQ ID NOs: 25, 26, 28 or 29, or having at least 98% identity thereof, indicating that a Lactobacillus reuteri as claimed is publicly known at the time of invention.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the current invention to combine the teachings of Hibberd and WP_003670646.1, Genbank: CP027805.1 and/or Wang to arrive at the invention as claimed. One would have been motivated to do so to substitute the probiotic microorganisms taught in Hibberd by the L. reuteri strains of WP_003670646.1, Genbank: CP027805.1 and/or Wang to evaluate the effect of these strains in the study of Hibberd. Additionally, such combination or substitution of one element for another known in the field to have the same function, is evidence that the claimed invention may be found obvious. See e.g., KSR International v. Teleflex Inc., 82 U.S.P.Q.2d 1385, at 1395. Therefore, the instant invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding claims 7, 32 and 51, it would have been obvious to use more than one different L. reuteri strains known at the time of invention in a composition in the study of Hibberd. Such combination or substitution of one element for another known in the field to have the same function, is evidence that the claimed invention may be found obvious. See e.g., KSR International v. Teleflex Inc., 82 U.S.P.Q.2d 1385, at 1395. As to the claimed ratio of 0.75-1.5 to 1, one would have been able to arrive at it through routine experimental optimization unless there is evidence that the claimed ratio is critical. See MPEP 2144.05.
Claims 17, 19-20, 34-35, 39-40 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Hibberd et al. (WO 2006/124630 A2, published on Nov. 23, 2006; submitted in IDS filed on Oct. 11, 2023) in view of WP_003670646.1 (aminotransferase [Limosilactobacillus reuteri]. Dated Oct. 11, 2019), Genbank: CP027805.1 (Limosilactobacillus reuteri strain WHH1689 chromosome, complete genome. Dated Apr. 26, 2018) and/or Wang et al. (CN 105219683 A, published on Jan. 6, 2016), as applied above, and further in view of Sundararaman et al. (Applied Microbiology and Biotechnology (2020) 104:8089–8104. Published online: Aug. 19, 2020), and/or Ogawa et al. (British Journal of Nutrition (2006), 95, 430–434).
These claims specify that the infectious respiratory diseases are ones other than influenza virus infection, such coronavirus vaccine, a porcine reproductive and respiratory syndrome (PRRS) vaccine, etc.
Relevance of Hibberd, WP_003670646.1, Genbank: CP027805.1 and Wang is set forth above. Hibberd teaches that the invention can also be used for subjects with other viral infections, such as human immunodeficiency virus and hepatitis virus. See page 4, para 4. However, these references are silent on coronaviruses.
Sundararaman reviews studies on the role of probiotics to combat viral infections with emphasis on COVID-19. In this review, the authors comprehensively discuss the prophylactic and supportive therapeutic role of probiotics for the management of COVID-19. In addition, the unique role of probiotics to modulate the gut microbe and assert gut homeostasis and production of interferon as an antiviral mechanism is described. Further, the regulatory role of probiotics on gut-lung axis and mucosal immune system for the potential antiviral mechanisms is reviewed and discussed. See Abstract. Sundararaman teaches that BioGaia’s strain L. reuteri DSM 17938 has been shown to protect against upper respiratory tract infection and gastrointestinal problems in children aged 6 months to 3 years old (Gabryszewski et al. 2011). See page 8096, right column, para 1.
Ogawa teaches that they recently reported that synbiotic Lactobacillus casei subsp. casei together with specific substrate dextran elicited an enhancement in humoral immune response against bovine serum albumin (BSA) as a model antigen in BALB/c mice. The present study was designed to evaluate the oral immunoadjuvant effects of the synbiotic in layer chickens. Oral administration of L. casei subsp. casei significantly enhanced the production of anti-BSA antibody in DSD-fed chickens. In addition, among bacterial numbers tested, 106 CFU L. casei subsp. casei together with dextran induced an effective increase in humoral immune response to mixed inactivated vaccines against Newcastle disease and avian infectious bronchitis, and the treatment may be advantageous in protecting against these infectious diseases in chickens in actual application. These results suggest that dietary supplementation of L. casei subsp. casei with dextran leads to immunomodulation of humoral immune responses. See Abstract.
Accordingly, teachings of Sundararaman and Ogawa indicate the potential beneficial functions of probiotic microorganisms, including Lactobacillus bacteria, in the management of respiratory viral infections, including coronaviruses SARS-CoV-2 and IBV.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the current invention to combine the teachings of Hibberd, WP_003670646.1, Genbank: CP027805.1, Wang, Sundararaman and Ogawa to arrive at the invention as claimed. One would have been motivated to do so to apply the potential beneficial functions of the probiotic L. reuteri in the management of subjects with coronavirus infections, as suggested in Sundararaman and Ogawa.
Regarding claim 34, a skilled artisan would have found it obvious to administer a probiotic composition comprising a L. reuteri to a subject of any animal species to promote the subject’s health, when there is a need, including felines or canines in need of a coronavirus vaccine.
Double Patenting Rejection
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3, 5-8, 11, 13, 15-17, 19-20, 25, 28-35, 39-40, 43, 46-48, 50-51 and 53 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-31 of US Patent 12427174 B2 in view of the prior art references cited in the art rejections above.
Although the conflicting claims are not identical, they are not patentably distinct from each other. Both sets of claims encompass a composition comprising probiotic microorganism Lactobacillus reutri strain 3632 (ATCC PTA-126788, corresponding to SEQ ID NOs: 1-24, 26, 49-55) and/or strain 3630 (ATCC PTA-126787, corresponding to SEQ ID NOs: 25, 27-43, 44-48), or a method of administering such a composition. The difference is that the instant claims further encompass an infectious respiratory disease vaccine to be administered to a subject together with the probiotic microorganism.
As indicated in the art rejections above, Hibberd teaches the beneficial effects of probiotic microorganisms, including L. reuteri, in promoting health of a subject and enhancing immune responses to subjects receiving influenza vaccines. Teachings of Sundararaman and Ogawa indicate that probiotic microorganisms, including Lactobacillus sp. are considered to have potential beneficial functions in the management of coronavirus infections (e.g., SARS-CoV-2 and IBV) in both human and non-human subjects.
It would have been prima facie obvious for one of ordinary skill in the art to arrive at the current claims from the reference claims based on the teachings of the references cited in the art rejections above. One would have been motivated to do so to apply the potentially beneficial functions of the L. reuteri compositions of the reference claims to subjects receiving vaccines against respiratory infectious diseases. Also see discussions in the art rejections above.
Between method claims and composition claims, the rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
Accordingly, claims 1, 3, 5-8, 11, 13, 15-17, 19-20, 25, 28-35, 39-40, 43, 46-48, 50-51 and 53 are unpatentable over claims 1-31 of US Patent 12427174 B2.
Claims 1, 3, 5-8, 11, 13, 15-17, 19-20, 25, 28-35, 39-40, 43, 46-48, 50-51 and 53 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 62-86 of US Application 17502716 in view of the prior art references cited in the art rejections above.
Although the conflicting claims are not identical, they are not patentably distinct from each other. Both sets of claims encompass a process of administering to a subject a composition comprising probiotic microorganism Lactobacillus reutri strain 3632 (ATCC PTA-126788, corresponding to SEQ ID NOs: 1-24, 26, 49-55) and/or strain 3630 (ATCC PTA-126787, corresponding to SEQ ID NOs: 25, 27-43, 44-48). The difference is that the instant claims further encompass an infectious respiratory disease vaccine to be administered to a subject together with the probiotic microorganism.
As indicated in the art rejections above, Hibberd teaches the beneficial effects of probiotic microorganisms, including L. reuteri, in promoting health of a subject and enhancing immune responses to subjects receiving influenza vaccines. Teachings of Sundararaman and Ogawa indicate that probiotic microorganisms, including Lactobacillus sp. are considered to have potential beneficial functions in the management of coronavirus infections (e.g., SARS-CoV-2 and IBV) in both human and non-human subjects.
It would have been prima facie obvious for one of ordinary skill in the art to arrive at the current claims from the reference claims based on the teachings of the references cited in the art rejections above. One would have been motivated to do so to apply the potentially beneficial functions of the process of the reference claims to subjects receiving vaccines against respiratory infectious diseases. Also see discussions in the art rejections above.
Between method claims and composition claims, the rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
Accordingly, claims 1, 3, 5-8, 11, 13, 15-17, 19-20, 25, 28-35, 39-40, 43, 46-48, 50-51 and 53 are unpatentable over claims 62-86 of US Application 17502716.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JANET ANDRES, on (571) 272-0867, can be reached. 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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/
Primary Examiner, Art Unit 1671