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 .
Response to Amendment
Applicant’s amendment dated 28-February-2026, 7/29/26 and 8/19/26 are entered and considered. Since previous office action mailed 10/28/2025, Applicant filed claim amendment filed 2/28/2026 which was drawn to a method of producing an injectable vaccine. Independent claim 345 now requires the following integrated process: 1. Infection of Spodoptera frugiperda insect cells with recombinant baculovirus; 2. Bioreactor culturing to produce recombinant protein; 3. Transfer from the bioreactor to a filter system comprising centrifuge and/or depth filtration; 4. Purification using a chromatography column comprising a stationary phase selected from ion exchange, hydrophobic interaction, or affinity adsorbents; 5. Filtering using one or more filter types selected from microfiltration, ultrafiltration, diafiltration, or tangential flow filtration; and 6. Mixing the recombinant protein with at least one surfactant to produce the injectable recombinant protein vaccine composition. The Office issued Notice of Non-Responsive Amendment 6/1/2026 because newly submitted claim 2/28/2026 was drawn to an invention that is independent or distinct from the invention originally claimed. Applicant filed a new claim amendment filed 7/29/2026 which was drawn to an injectable vaccine composition comprising: 1. treated water treated with three or more specifically identified water-treatment systems; and 2. a purified recombinant protein derived from pupal ovarian cells of Spodoptera frugiperda, wherein the cells are infected with a recombinant baculovirus to produce the recombinant protein and the recombinant protein is purified. However, this claim set has a defect. Examiner pointed out in the phone interview with Applicant on 8/18/2026 that claim set 7/29/2026 presented new claim 366, but claim 366 was present in claim set filed 9/16/2025. Examiner requested Applicant to file a new claim set with correction. Applicant filed a new claim set filed 8/19/2026 which is drawn to an injectable vaccine composition comprising: 1. treated water treated with three or more specifically identified water-treatment systems; and 2. a purified recombinant protein derived from pupal ovarian cells of Spodoptera frugiperda, wherein the cells are infected with a recombinant baculovirus to produce the recombinant protein and the recombinant protein is purified.
Claim Status
Claim(s) 1-344, 357 and 360-366 were canceled.
Claim 367-368 was added.
Claims 345-356, 358-359 and 367-368 are pending and under consideration.
Withdrawn Rejections
Objections of canceled claims 360-361 and 366 are moot.
NEW - Claim Objections
(necessitated by amendments)
Claim 368 is objected to because of the following informalities: “includes” should read “has” because “include” is used to define components in the composition and “has” is used to define functional property. The “electrical conductivity” is functional property of the treated water, not a component in the treated water. Appropriate correction is required.
MAINTAINED - 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 345-356, 358-359 and 367-368 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a “written description” rejection.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Regents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., binding to antigen, high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus take into account the state of the art at the time of the invention. For antibodies, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor, 97 USPQ2d at 1875 (“[T]he application only provides amino acid sequence information (a molecular description of the antibody) for a single mouse variable region, i.e., the variable region that the mouse A2 antibody and the chimeric antibody have in common. However, the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims.”). A chimeric antibody shares the full heavy and light chain variable regions with the corresponding mouse antibody; that is, the structure shared between a mouse and chimeric antibody would generally be expected to conserve the antigen binding activity.
Even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
Additionally, “An adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.” Amgen Inc v. Sanofi 124 USPQ2d 1354, 1361 (Fed. Cir. 2017). “Further, the “newly characterized antigen” test flouts basic legal principles of the written description requirement. Section 112 requires a “written description of the invention.” But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The test thus contradicts the statutory “quid pro quo” of the patent system where “one describes an invention, and, if the law's other requirements are met, one obtains a patent.” Ariad, 598 F.3d at 1345.” Amgen at 1362.
Claim Analysis
Instant claims are drawn to an injectable vaccine composition comprising: treated water, the treated water is treated with three or more water treatment systems selected from the group consisting of an absorber, an adsorber, an anion, a cation, a distillation system, an ion exchanger resin, a membrane, a microwave unit, an ozone unit, an ultraviolet unit; and a purified recombinant protein derived from pupal ovarian cells of Spodoptera frugiperda wherein the pupal ovarian cells are infected with a recombinant baculovirus to produce a recombinant protein, the recombinant protein is purified to produce the purified recombinant protein.
Instant specification did not disclose any vaccine composition comprising purified recombinant protein. Instant claims encompass any vaccine composition comprising any type of recombinant protein because instant claims do not define the structure of the recombinant protein (i.e. amino acid sequence). Since instant specification did not disclose a single species of vaccine composition, it does not provide adequate written description for the broadly claimed genus encompassing any recombinant protein as claimed by instant claims. Without any experimental evidence disclosed by instant specification, one of ordinary skill in the art would not recognize that applicants were in possession of a single species of vaccine composition, let alone a broad genus encompassing any type of recombinant protein as claimed by instant claims.
The disclosure therefore does not show that applicant was in possession of the necessary common attributes or features possessed by the members of the claimed genus. Accordingly, the skilled artisan would not recognize that applicants were in possession of the invention as broadly claimed at the time the application was filed.
Response to Arguments
In the response filed on 8/19/2026, Applicant argued at page 4,
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Applicant's arguments have been fully considered but they are not persuasive. The disclosure of well-known procedure of protein production does not show that Applicants are in possession of the claimed protein. The instant specification did not even disclose the name of the claimed protein, let alone specific structure of the claimed protein (i.e. amino acid sequence).
Even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
Applicant argued at page 7,
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Applicant's arguments have been fully considered but they are not persuasive. Instant specification did not even disclose the name of the claimed protein, let alone specific structure of the claimed protein (i.e. amino acid sequence).
“An adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.” Amgen Inc v. Sanofi 124 USPQ2d 1354, 1361 (Fed. Cir. 2017). “Further, the “newly characterized antigen” test flouts basic legal principles of the written description requirement. Section 112 requires a “written description of the invention.” But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The test thus contradicts the statutory “quid pro quo” of the patent system where “one describes an invention, and, if the law's other requirements are met, one obtains a patent.” Ariad, 598 F.3d at 1345.” Amgen at 1362.
Applicant argues at page 6 that the Office Action characterized the prior claims as covering ‘any type of recombinant protein.’ That characterization does not give effect to all limitations of amended Claim 345.
Applicant's arguments have been fully considered but they are not persuasive. As discussed above, instant claims do not even recite the name of the claimed protein. Therefore, instant claims encompass “any type of recombinant protein” produced by Spodoptera frugiperda expression system.
MAINTAINED / NEW - Claim Rejections - 35 USC § 103
(necessitated by amendments)
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) 345-352, 355-356, and 358-359 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox (Vaccine 30 (2012) 1759-1766) in view of Jain et al (Advanced Drug Delivery Reviews 93 (2015) 42-55) and Pramanick et al (Pharma Times, vol. 45, No. 3, March 2013, 65-77).
Regarding claim 345-346, 352, 355, and 359, Cox teaches “The baculovirus-insect cell expression system is a well-known tool for the production of complex proteins. The technology is also used for commercial manufacture of various veterinary and human vaccines” (abstract). Cox teaches “The process steps to produce a recombinant protein in insect cells are shown in Fig. 1. As described earlier the protective antigen is inserted into the baculovirus to generate the recombinant virus (“plug and play”) that is amplified in insect cells to generate the Working Virus Bank (WVB). The insect cells are grown in a bioreactor and infected with the WVB that has been expanded in insect cells at a scale that is approximately 100-fold smaller than the protein production bioreactor. Cells are separated from the media using centrifugation and, dependent on the product that is being produced, either the cell paste or the supernatant is further processed. The protein of interest is solubilized (when applicable) and processed using depth filtration. It is then captured using column chromatography and further purified using additional chromatography. Potential further contaminants can be removed, if required, using membrane filtration technology and, finally, the product is brought into its final buffer composition using ultrafiltration. The process steps indicated in italics are routinely used in monoclonal antibody production” (page 1764, left column). Cox teaches “The baculovirus-insect cell expression system, often referred to as BEVS, is well known as a tool for producing complex proteins, and providing rapid access to biologically active proteins. This protein production platform has been extensively explored for the production of viral and parasitic antigens and, more recently, vaccines have been commercialized demonstrating its potential as a commercial manufacturing technology. … The baculovirus particles or virions contain a large double-stranded DNA genome that on average, depending on the virus species, is 130 kb pairs in size. It can be easily characterized, genetically manipulated and propagated in cell lines derived from a.o. the fall armyworm Spodoptera frugiperda (SF) or the cabbage looper Trichoplusia ni (T. ni), both of which grow well in suspension cultures” (page 1761, left column). It is well known in the art that commercially available commonly used Sf9 and Sf21 insect cell lines are developed from ovarian cells of Spodoptera frugiperda (SF). Cox teaches recombinant “protective antigen” and infectious disease for which the vaccine is used (Table 3, page 1763).
Regarding claim limitation “treated water, the treated water is treated with three or more water treatment systems selected from the group consisting of an absorber, an adsorber, an anion, a cation, a distillation system, an ion exchanger resin, a membrane, a microwave unit, an ozone unit, an an ultraviolet unit”, it is well known in the art that pharmaceutical compositions comprising proteins are formulated in highly purified water. The claim limitation “the treated water is treated with three or more water treatment systems selected from the group consisting of an absorber, an adsorber, an anion, a cation, a distillation system, an ion exchange resin, a membrane, a microwave unit, an ozone unit, and an ultraviolet unit” corresponds to the process of “product-by-process claim” and does not change the structure or substance of the claimed product (i.e. the treated water in this case).
Regarding claims 347-348, Cox teaches “Ion exchange (IEX) columns” and “hydrophobic interaction chromatography (HIC) column” (Figure 1; reproduced below). These chromatography techniques are well known in the art of protein purification.
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Regarding claim 349, gel filtration chromatography is obvious to one of ordinary skill in the art because chromatography columns such as Ni-affinity column, Co-affinity column, ion exchange column, hydrophobic column, and gel filtration column (also known as “size exclusion column”) are well known in the art and also commonly employed in the protein purification art. Skilled artisan usually test these columns to see whether protein-of-interest bind to these columns and therefore these techniques are routine experimentation to one of ordinary skill in the art. Furthermore, instant claim 349 corresponds to product-by-process claim because instant claim 349 claims product (i.e. composition), not process. The wherein-clause of instant claim 349 corresponds to process in product-by-process claim. As long as the product of reference teaches same product, the claimed product is taught by the product of reference because the process of instant claim does not change the structure (i.e. amino acid sequence of the protein) of the claimed product.
Regarding claim 350, instant claims recite commonly used purification techniques which are well known in the art. Therefore, claim 350 is also obvious to one of ordinary skill in the art. Furthermore, as discussed above, claim 350 also corresponds to product-by-process claim.
Regarding claim 351, skilled artisan in the art of protein purification routinely freezes expression host cells in liquid nitrogen and store it at -70C deep freezer before purification and thaw it just before starting purification steps. Therefore, claim 351 recites about the process of purification which is obvious to one of ordinary skill in the art. Furthermore, as discussed above, the process of purification does not change the structure of the claimed product.
Regarding claim 356, reverse phase chromatography is routinely utilized in protein purification art and obvious to one of ordinary skill in the art. Furthermore, as discussed above, the process of purification does not change the structure of the claimed product in the product-by-process claim.
Regarding claim 358, as discussed above, the recombinant protein antigens taught by Cox does not comprise mRNA. There is no evidence to the contrary.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have produced vaccine composition comprising purified recombinant protein to use it as a therapeutic agent because Cox teaches well-known techniques of producing protein in Spodoptera frugiperda. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because Cox teaches well-known techniques of producing protein in Spodoptera frugiperda. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 345-356 and 358-359 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox (Vaccine 30 (2012) 1759-1766) in view of Jain et al (Advanced Drug Delivery Reviews 93 (2015) 42-55) and Pramanick et al (Pharma Times, vol. 45, No. 3, March 2013, 65-77) as applied to claims 345-352, 355-356, and 358-359 above, and further in view of Wrapp et al (Science 367, 1260-1263 (2020)).
Instant application claims domestic benefit on parent case 15/242,579 (filed 8/21/2016). However, parent case 15/242,579 does not support vaccine composition that provides immunity to coronavirus disease as claimed by instant claims 353-354 and 361-364, and therefore EFD of instant claims 353-354 and 361-364 is the filing date of instant application (3/18/2020).
Wrapp et al was published online on 02/19/2020 (see at the end of cited reference) and therefore available as 102(a)(1) art.
Regarding claims 345-352, 355-356, and 358-359, teachings of Cox were discussed above.
However, Cox does not teach vaccine that provide immunity to coronavirus disease.
Regarding claims 353-354, Wrapp teaches cryo-EM structure of the 2019-nCoV spike protein. 2019-nCoV is an alternative name of SARS-CoV-2. Wrapp teaches that the CoV spike (S) glycoprotein is a key target for vaccines (abstract).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to have applied insect cell vaccine protein expression system taught by Cox to express CoV spike (S) glycoprotein because Wrapp teaches that the CoV spike (S) glycoprotein is a key target for vaccines (abstract). Since insect cell vaccine expression system was well known in the art and coronavirus pandemic required a new vaccine for coronavirus disease, one of ordinary skill in the art would be motivated to apply insect cell expression system to produce vaccine for coronavirus disease. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because prior art teaches that insect cell expression system for vaccine production was effective in production of vaccine. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 345-352, 355-356, 358-359 and 367 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox (Vaccine 30 (2012) 1759-1766) in view of Jain et al (Advanced Drug Delivery Reviews 93 (2015) 42-55) and Pramanick et al (Pharma Times, vol. 45, No. 3, March 2013, 65-77) as applied to claims 345-352, 355-356, and 358-359 above, and further in view of Ji et al (US2013/0078232; PTO-892).
Regarding claims 345-352, 355-356, and 358-359, teachings of Cox were discussed above.
However, Cox does not teach vaccine composition comprising surfactant.
Regarding claim 367, Ji teaches compositions and methods useful for stabilizing protein-containing formulation (title). Ji teaches “polysorbates 20 and 80 (Tween® 20 and Tween® 80) are used in the formulation of biotherapeutic products for both preventing surface adsorption and as stabilizers against protein aggregation” [003]. Polysorbate is a well-known surfactant.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added polysorbates 20 or polysorbate 80 into a vaccine composition in order to stabilize protein in the vaccine composition because Ji teaches that polysorbates 20 or polysorbate 80 stabilize proteins in the pharmaceutical composition. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because Ji teaches that polysorbates 20 or polysorbate 80 stabilize proteins in the pharmaceutical composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 345-352, 355-356, 358-359 and 368 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox (Vaccine 30 (2012) 1759-1766) in view of Jain et al (Advanced Drug Delivery Reviews 93 (2015) 42-55) and Pramanick et al (Pharma Times, vol. 45, No. 3, March 2013, 65-77) as applied to claims 345-352, 355-356, and 358-359 above, and further in view of Tech bulletin by Aquatherm (hereinafter Aquatherm; HIGH PURITY WATER SYSTEMS - Aquatherm; Date Issued: 9 December 2014; PTO-892).
Regarding claims 345-352, 355-356, and 358-359, teachings of Cox were discussed above.
However, Cox does not teach water with conductivity ranging from 0.10 to 100 microsiemens.
Regarding claim 368, Aquatherm teaches conductivity of deionized water (Figure 1; reproduced below). As shown in Figure 1, pure water has conductivity range from 0.1 microsiemens to 1 microsiemens.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used highly purified water having conductivity lower than 1 microsiemens because one of ordinary skill in the art would recognize that the injectable vaccine composition must have highly pure water because it is administered into human body. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because Aquatherm teaches that pure water has conductivity range from 0.1 microsiemens to 1 microsiemens. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
In the response filed on 8/19/2026, Applicant argued at page 10 that Cox does not teach the claimed treatment of formulation water.
Applicant's arguments have been fully considered but they are not persuasive. As discussed above, it is well known in the art that pharmaceutical compositions comprising proteins are formulated in highly purified water. Therefore, pharmaceutical composition comprising the treated water is obvious to one of ordinary skill in the art. Furthermore, the claim limitation “the treated water is treated with three or more water treatment systems selected from the group consisting of an absorber, an adsorber, an anion, a cation, a distillation system, an ion exchange resin, a membrane, a microwave unit, an ozone unit, and an ultraviolet unit” corresponds to the process of “product-by-process claim” and does not change the structure or substance of the claimed product (i.e. the treated water in this case).
Applicant argued at page 11 that the Office has not established that the prior art water is identical or substantially identical.
Applicant's arguments have been fully considered but they are not persuasive. It is well known in the art that pharmaceutical composition is formulated in ultrapure water or pure water as taught by Aquatherm. As discussed above, dependent claim 368 claims electrical conductivity which corresponds to pure water. Therefore, the water of prior art is identical or substantially identical to the instant invention.
Conclusion
No claim is allowed.
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 CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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