CTFR 18/027,696 CTFR 81384 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Applicant’s amendment and remarks filed on 3/3/2026 are acknowledged. Claims 4-5 and 9-13 are amended. Claims 1-15 are pending and are currently under examination. Information Disclosure Statement The information disclosure statement filed on 3/3/2026 has been considered. A signed copy is enclosed. Claim Objections 12-151-08 AIA 07-43 12-51-08 Claim s 11 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim Rejections Withdrawn The rejection of claims 3-4, 9-11, and 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly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the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn in light of applicant’s amendment thereto. The rejection of claim 13 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,266,730 is withdrawn in light of applicant’s amendment thereto. The rejection of claim 13 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12174188 is withdrawn in light of applicant’s amendment thereto. The rejection of claim 13 on the ground of nonstatutory double patenting as being unpatentable over claims 212-230 of copending Application No. 17913503 (reference application) is withdrawn in light of applicant’s amendment thereto. The rejection of claim 13 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18978388 (reference application) is withdrawn in light of applicant’s amendment thereto. The rejection of claim 13 under 35 U.S.C. 102(a)(1) as being anticipated by Faustman et al (PLOS One, 7(8)e41756, 1-16; 8/8/2012) is withdrawn in light of applicant’s amendment thereto. Claim Rejections Maintained Double Patenting 08-33 AIA 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. The rejection of claims 1-10 and 14-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,266,730 is maintained for the reasons set forth in the previous office action. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The instant claims are drawn to methods for prophylactic treatment of coronavirus infection by administering at least two doses of BCG to a type I diabetic. The patented claims are drawn to methods of intradermally administering at least two doses of a BCG vaccine to diabetic patients. The claims recite diabetes and then specifically recite type 2 diabetes. The broader recitation therefore includes type 1 diabetes. The patented claims recite a dose that is “about” the dose recited in instant claim 4. The patients must have high cholesterol which is a co-morbidity. “At least two” doses includes three and greater doses and any second dose serves as a booster dose. Though the patented claims are silent with regard to prophylaxis of coronavirus, if the method works as applicant claims, administration of the BCG vaccine would necessarily prevent coronavirus infections. With regard to the limitations of claims 3, 6-8, and 14, it would have been obvious to administer the BCG vaccine according to the claimed method because it is useful to vaccinate subjects in each of these populations and there is no reason to suspect that vaccination would not be successful in these populations. Applicant argues: 1. That the claims are based on the inventor’s recognition and clinical demonstration of a new therapeutic use. Applicant argues that they made the unexpected and clinically significant observation that diabetic patients who received two doses of BCG experience milder symptoms of COVID-19 than their non-diabetic household members. 2. That Federal Circuit precedent requires that an inherent feature be inevitably present whenever the prior-art method is practiced, not conditionally present if a later-claimed hypothesis proves correct. Applicant asserts that coronavirus prophylaxis is not required by or inherent in administering BCG for treatment of type I diabetes, as evidenced by the absence of any disclosure or suggestion of coronavirus prevention in the cited patent and by the “need for a specifically designed, multi-dose randomized clinical trial to establish this new therapeutic use.” Applicant states that coronavirus prophylaxis is demonstrated only through a clinical trial and that protection is shown by comparison, not as an automatic consequence. Applicant showed that the efficacy of BCG to prevent Covid-19 infections was 92% 3. That, absent this recognition and demonstration of prophylactic treatment by the inventor, the skilled person in the art would not arrive at the invention without inventive ingenuity. Applicant’s arguments have been fully considered and are not persuasive for the following reasons: Regarding argument 1, the basis for applicant’s claims is not relevant to what was disclosed in the prior art. Applicant’s new recognition of something that was already happening does not make the method novel. Applicant’s arguments with regard to unexpected results are not persuasive for two reasons. First, unexpected results are not relevant to anticipation, but instead apply only to a determination of obviousness. Second, the results shown in the specification do not have a nexus to the claimed invention. The results in the specification are limited to a specific BCG strain and to a decrease in symptoms caused by COVID-19. This is not commensurate with the scope of the instant claims. Regarding argument 2 and 3, applicant’s hypothesis does not alter the physiological effects that occur after vaccination with BCG. When one administers BCG to a diabetic, their decisions, wants, desires, and knowledge of what will happen do not alter what will actually happen within the body. What happens is an inherent feature of BCG vaccination. According to applicant’s arguments, what will happen is that COVID-19 will be prevented 92% of the time. Therefore, when the prior art administrations occurred, COVID-19 was prevented 92% of the time. Whether that was recognized or not does not alter the physiological processes that were induced by the vaccination. This feature is inevitably present. Applicant is correct that prophylaxis is demonstrated by a trial, but demonstration of prophylaxis is not the same as the prophylaxis itself. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase “which provides improved playing and handling characteristics” in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to “a human in need thereof,” the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); Nantkwest , Inc. v. Lee, 686 Fed. App'x 864, 867 (Fed. Cir. 2017) (nonprecedential) (The court found that the preamble phrase “treating a cancer” “’require[s] lysis of many cells, in order to accomplish the goal of treating cancer’ and not merely lysing one or a few cancer cells.”); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002) (A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase “rich in glucosinolates” helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently “rich in glucosinolates”)). In the instant case, the required method steps are disclosed in the prior art. The preamble of the claim reciting the intended use of coronavirus prophylaxis does not alter the structural steps of the claimed invention. The rejection of claims 1-10 and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12174188 is maintained for the reasons set forth in the previous office action. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The instant claims are drawn to methods for prophylactic treatment of coronavirus infection by administering at least two doses of BCG to a type I diabetic. The patented claims are drawn to methods of intradermally administering at least two doses of a BCG vaccine to patients with type 1 diabetes. The patented claims recite a dose that is “about” the dose recited in instant claim 4. “At least two” doses includes three and greater doses and any second dose serves as a booster dose. Though the patented claims are silent with regard to prophylaxis of coronavirus, if the method works as applicant claims, administration of the BCG vaccine would necessarily prevent coronavirus infections. With regard to the limitations of claims 3, 6-8, and 14-15, it would have been obvious to administer the BCG vaccine according to the claimed method because it is useful to vaccinate subjects in each of these populations and there is no reason to suspect that vaccination would not be successful in these populations. Applicant argues: 1. That the claims are based on the inventor’s recognition and clinical demonstration of a new therapeutic use. Applicant argues that they made the unexpected and clinically significant observation that diabetic patients who received two doses of BCG experience milder symptoms of COVID-19 than their non-diabetic household members. 2. That Federal Circuit precedent requires that an inherent feature be inevitably present whenever the prior-art method is practiced, not conditionally present if a later-claimed hypothesis proves correct. Applicant asserts that coronavirus prophylaxis is not required by or inherent in administering BCG for treatment of type I diabetes, as evidenced by the absence of any disclosure or suggestion of coronavirus prevention in the cited patent and by the “need for a specifically designed, multi-dose randomized clinical trial to establish this new therapeutic use.” Applicant states that coronavirus prophylaxis is demonstrated only through a clinical trial and that protection is shown by comparison, not as an automatic consequence. Applicant showed that the efficacy of BCG to prevent Covid-19 infections was 92% 3. That, absent this recognition and demonstration of prophylactic treatment by the inventor, the skilled person in the art would not arrive at the invention without inventive ingenuity. Applicant’s arguments have been fully considered and are not persuasive for the following reasons: Regarding argument 1, the basis for applicant’s claims is not relevant to what was disclosed in the prior art. Applicant’s new recognition of something that was already happening does not make the method novel. Applicant’s arguments with regard to unexpected results are not persuasive for two reasons. First, unexpected results are not relevant to anticipation, but instead apply only to a determination of obviousness. Second, the results shown in the specification do not have a nexus to the claimed invention. The results in the specification are limited to a specific BCG strain and to a decrease in symptoms caused by COVID-19. This is not commensurate with the scope of the instant claims. Regarding argument 2 and 3, applicant’s hypothesis does not alter the physiological effects that occur after vaccination with BCG. When one administers BCG to a diabetic, their decisions, wants, desires, and knowledge of what will happen do not alter what will actually happen within the body. What happens is an inherent feature of BCG vaccination. According to applicant’s arguments, what will happen is that COVID-19 will be prevented 92% of the time. Therefore, when the prior art administrations occurred, COVID-19 was prevented 92% of the time. Whether that was recognized or not does not alter the physiological processes that were induced by the vaccination. This feature is inevitably present. Applicant is correct that prophylaxis is demonstrated by a trial, but demonstration of prophylaxis is not the same as the prophylaxis itself. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase “which provides improved playing and handling characteristics” in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to “a human in need thereof,” the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); Nantkwest , Inc. v. Lee, 686 Fed. App'x 864, 867 (Fed. Cir. 2017) (nonprecedential) (The court found that the preamble phrase “treating a cancer” “’require[s] lysis of many cells, in order to accomplish the goal of treating cancer’ and not merely lysing one or a few cancer cells.”); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002) (A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase “rich in glucosinolates” helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently “rich in glucosinolates”)). In the instant case, the required method steps are disclosed in the prior art. The preamble of the claim reciting the intended use of coronavirus prophylaxis does not alter the structural steps of the claimed invention. The rejection of claims 1-10 and 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 212-230 of copending Application No. 17913503 (reference application) is maintained for the reasons set forth in the previous office action. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons The instant claims are drawn to methods for prophylactic treatment of coronavirus infection by administering at least two doses of BCG to a type I diabetic. The patented claims are drawn to methods of intradermally administering at least two doses of a BCG vaccine to patients with type 1 diabetes. The patented claims recite a dose that is “about” the dose recited in instant claim 4. “At least two” doses includes three and greater doses and any second dose serves as a booster dose. Though the patented claims are silent with regard to prophylaxis of coronavirus, if the method works as applicant claims, administration of the BCG vaccine would necessarily prevent coronavirus infections. With regard to the limitations of claims 3, 6-8, and 14-15, it would have been obvious to administer the BCG vaccine according to the claimed method because it is useful to vaccinate subjects in each of these populations and there is no reason to suspect that vaccination would not be successful in these populations. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Applicant argues: 1. That the claims are based on the inventor’s recognition and clinical demonstration of a new therapeutic use. Applicant argues that they made the unexpected and clinically significant observation that diabetic patients who received two doses of BCG experience milder symptoms of COVID-19 than their non-diabetic household members. 2. That Federal Circuit precedent requires that an inherent feature be inevitably present whenever the prior-art method is practiced, not conditionally present if a later-claimed hypothesis proves correct. Applicant asserts that coronavirus prophylaxis is not required by or inherent in administering BCG for treatment of type I diabetes, as evidenced by the absence of any disclosure or suggestion of coronavirus prevention in the cited patent and by the “need for a specifically designed, multi-dose randomized clinical trial to establish this new therapeutic use.” Applicant states that coronavirus prophylaxis is demonstrated only through a clinical trial and that protection is shown by comparison, not as an automatic consequence. Applicant showed that the efficacy of BCG to prevent Covid-19 infections was 92% 3. That, absent this recognition and demonstration of prophylactic treatment by the inventor, the skilled person in the art would not arrive at the invention without inventive ingenuity. Applicant’s arguments have been fully considered and are not persuasive for the following reasons: Regarding argument 1, the basis for applicant’s claims is not relevant to what was disclosed in the prior art. Applicant’s new recognition of something that was already happening does not make the method novel. Applicant’s arguments with regard to unexpected results are not persuasive for two reasons. First, unexpected results are not relevant to anticipation, but instead apply only to a determination of obviousness. Second, the results shown in the specification do not have a nexus to the claimed invention. The results in the specification are limited to a specific BCG strain and to a decrease in symptoms caused by COVID-19. This is not commensurate with the scope of the instant claims. Regarding argument 2 and 3, applicant’s hypothesis does not alter the physiological effects that occur after vaccination with BCG. When one administers BCG to a diabetic, their decisions, wants, desires, and knowledge of what will happen do not alter what will actually happen within the body. What happens is an inherent feature of BCG vaccination. According to applicant’s arguments, what will happen is that COVID-19 will be prevented 92% of the time. Therefore, when the prior art administrations occurred, COVID-19 was prevented 92% of the time. Whether that was recognized or not does not alter the physiological processes that were induced by the vaccination. This feature is inevitably present. Applicant is correct that prophylaxis is demonstrated by a trial, but demonstration of prophylaxis is not the same as the prophylaxis itself. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase “which provides improved playing and handling characteristics” in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to “a human in need thereof,” the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); Nantkwest , Inc. v. Lee, 686 Fed. App'x 864, 867 (Fed. Cir. 2017) (nonprecedential) (The court found that the preamble phrase “treating a cancer” “’require[s] lysis of many cells, in order to accomplish the goal of treating cancer’ and not merely lysing one or a few cancer cells.”); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002) (A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase “rich in glucosinolates” helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently “rich in glucosinolates”)). In the instant case, the required method steps are disclosed in the prior art. The preamble of the claim reciting the intended use of coronavirus prophylaxis does not alter the structural steps of the claimed invention. The rejection of claims 1-10 and 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18978388 (reference application) is maintained for the reasons set forth in the previous office action. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons The instant claims are drawn to methods for prophylactic treatment of coronavirus infection by administering at least two doses of BCG to a type I diabetic. The patented claims are drawn to methods of intradermally administering at least two doses of a BCG vaccine to patients with type 1 diabetes. The patented claims recite a dose that is “about” the dose recited in instant claim 4. “At least two” doses includes three and greater doses and any second dose serves as a booster dose. Though the patented claims are silent with regard to prophylaxis of coronavirus, if the method works as applicant claims, administration of the BCG vaccine would necessarily prevent coronavirus infections. With regard to the limitations of claims 3, 6-8, and 14-15, it would have been obvious to administer the BCG vaccine according to the claimed method because it is useful to vaccinate subjects in each of these populations and there is no reason to suspect that vaccination would not be successful in these populations. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Applicant argues: 1. That the claims are based on the inventor’s recognition and clinical demonstration of a new therapeutic use. Applicant argues that they made the unexpected and clinically significant observation that diabetic patients who received two doses of BCG experience milder symptoms of COVID-19 than their non-diabetic household members. 2. That Federal Circuit precedent requires that an inherent feature be inevitably present whenever the prior-art method is practiced, not conditionally present if a later-claimed hypothesis proves correct. Applicant asserts that coronavirus prophylaxis is not required by or inherent in administering BCG for treatment of type I diabetes, as evidenced by the absence of any disclosure or suggestion of coronavirus prevention in the cited patent and by the “need for a specifically designed, multi-dose randomized clinical trial to establish this new therapeutic use.” Applicant states that coronavirus prophylaxis is demonstrated only through a clinical trial and that protection is shown by comparison, not as an automatic consequence. Applicant showed that the efficacy of BCG to prevent Covid-19 infections was 92% 3. That, absent this recognition and demonstration of prophylactic treatment by the inventor, the skilled person in the art would not arrive at the invention without inventive ingenuity. Applicant’s arguments have been fully considered and are not persuasive for the following reasons: Regarding argument 1, the basis for applicant’s claims is not relevant to what was disclosed in the prior art. Applicant’s new recognition of something that was already happening does not make the method novel. Applicant’s arguments with regard to unexpected results are not persuasive for two reasons. First, unexpected results are not relevant to anticipation, but instead apply only to a determination of obviousness. Second, the results shown in the specification do not have a nexus to the claimed invention. The results in the specification are limited to a specific BCG strain and to a decrease in symptoms caused by COVID-19. This is not commensurate with the scope of the instant claims. Regarding argument 2 and 3, applicant’s hypothesis does not alter the physiological effects that occur after vaccination with BCG. When one administers BCG to a diabetic, their decisions, wants, desires, and knowledge of what will happen do not alter what will actually happen within the body. What happens is an inherent feature of BCG vaccination. According to applicant’s arguments, what will happen is that COVID-19 will be prevented 92% of the time. Therefore, when the prior art administrations occurred, COVID-19 was prevented 92% of the time. Whether that was recognized or not does not alter the physiological processes that were induced by the vaccination. This feature is inevitably present. Applicant is correct that prophylaxis is demonstrated by a trial, but demonstration of prophylaxis is not the same as the prophylaxis itself. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase “which provides improved playing and handling characteristics” in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to “a human in need thereof,” the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); Nantkwest , Inc. v. Lee, 686 Fed. App'x 864, 867 (Fed. Cir. 2017) (nonprecedential) (The court found that the preamble phrase “treating a cancer” “’require[s] lysis of many cells, in order to accomplish the goal of treating cancer’ and not merely lysing one or a few cancer cells.”); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002) (A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase “rich in glucosinolates” helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently “rich in glucosinolates”)). In the instant case, the required method steps are disclosed in the prior art. The preamble of the claim reciting the intended use of coronavirus prophylaxis does not alter the structural steps of the claimed invention. 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. The rejection of claims 1-6, 12, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Faustman et al (PLOS One, 7(8)e41756, 1-16; 8/8/2012) is maintained for the reasons set forth in the previous office action. The instant claims are drawn to methods for prophylactic treatment of coronavirus infection by administering at least two doses of BCG to a type I diabetic. Faustman et al disclose methods of administering BCG vaccines to type 1 diabetics (see abstract). Though the reference is silent with regard to prophylaxis of coronavirus, if the method works as applicant claims, administration of the BCG vaccine would necessarily prevent coronavirus infections, including SARS CoV-2. As discussed in the rejection above, a previous vaccination with BCG serves as one of the doses. The dose is “about” the dose recited in claim 4 (see page 4, column 1). The dose is delivered intradermally to patients that are over 18 (see page 2, column 1 and page 4, column 1). Two doses are administered 4 weeks apart (see page 4, column 1). The second dose is a booster dose. The patients have established diabetes (see page 2, column 1). Some patients had EBV infection, which is a co-morbidity (see page 6, column 1). Applicant argues: 1. That the claims are based on the inventor’s recognition and clinical demonstration of a new therapeutic use. Applicant argues that they made the unexpected and clinically significant observation that diabetic patients who received two doses of BCG experience milder symptoms of COVID-19 than their non-diabetic household members. 2. That Federal Circuit precedent requires that an inherent feature be inevitably present whenever the prior-art method is practiced, not conditionally present if a later-claimed hypothesis proves correct. Applicant asserts that coronavirus prophylaxis is not required by or inherent in administering BCG for treatment of type I diabetes, as evidenced by the absence of any disclosure or suggestion of coronavirus prevention in the cited patent and by the “need for a specifically designed, multi-dose randomized clinical trial to establish this new therapeutic use.” Applicant states that coronavirus prophylaxis is demonstrated only through a clinical trial and that protection is shown by comparison, not as an automatic consequence. Applicant showed that the efficacy of BCG to prevent Covid-19 infections was 92% 3. That, absent this recognition and demonstration of prophylactic treatment by the inventor, the skilled person in the art would not arrive at the invention without inventive ingenuity. Applicant’s arguments have been fully considered and are not persuasive for the following reasons: Regarding argument 1, the basis for applicant’s claims is not relevant to what was disclosed in the prior art. Applicant’s new recognition of something that was already happening does not make the method novel. Applicant’s arguments with regard to unexpected results are not persuasive for two reasons. First, unexpected results are not relevant to anticipation, but instead apply only to a determination of obviousness. Second, the results shown in the specification do not have a nexus to the claimed invention. The results in the specification are limited to a specific BCG strain and to a decrease in symptoms caused by COVID-19. This is not commensurate with the scope of the instant claims. Regarding argument 2 and 3, applicant’s hypothesis does not alter the physiological effects that occur after vaccination with BCG. When one administers BCG to a diabetic, their decisions, wants, desires, and knowledge of what will happen do not alter what will actually happen within the body. What happens is an inherent feature of BCG vaccination. According to applicant’s arguments, what will happen is that COVID-19 will be prevented 92% of the time. Therefore, when the prior art administrations occurred, COVID-19 was prevented 92% of the time. Whether that was recognized or not does not alter the physiological processes that were induced by the vaccination. This feature is inevitably present. Applicant is correct that prophylaxis is demonstrated by a trial, but demonstration of prophylaxis is not the same as the prophylaxis itself. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase “which provides improved playing and handling characteristics” in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to “a human in need thereof,” the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); Nantkwest , Inc. v. Lee, 686 Fed. App'x 864, 867 (Fed. Cir. 2017) (nonprecedential) (The court found that the preamble phrase “treating a cancer” “’require[s] lysis of many cells, in order to accomplish the goal of treating cancer’ and not merely lysing one or a few cancer cells.”); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002) (A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase “rich in glucosinolates” helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently “rich in glucosinolates”)). In the instant case, the required method steps are disclosed in the prior art. The preamble of the claim reciting the intended use of coronavirus prophylaxis does not alter the structural steps of the claimed invention. Conclusion No claim is allowed. 07-39 AIA THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30. 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, Anne Gussow can be reached at 571-272-6047. 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. /BRIAN GANGLE/ Primary Examiner, Art Unit 1645 Application/Control Number: 18/027,696 Page 2 Art Unit: 1645 Application/Control Number: 18/027,696 Page 3 Art Unit: 1645 Application/Control Number: 18/027,696 Page 4 Art Unit: 1645 Application/Control Number: 18/027,696 Page 5 Art Unit: 1645 Application/Control Number: 18/027,696 Page 6 Art Unit: 1645 Application/Control Number: 18/027,696 Page 7 Art Unit: 1645 Application/Control Number: 18/027,696 Page 8 Art Unit: 1645 Application/Control Number: 18/027,696 Page 9 Art Unit: 1645 Application/Control Number: 18/027,696 Page 10 Art Unit: 1645 Application/Control Number: 18/027,696 Page 11 Art Unit: 1645 Application/Control Number: 18/027,696 Page 12 Art Unit: 1645 Application/Control Number: 18/027,696 Page 13 Art Unit: 1645 Application/Control Number: 18/027,696 Page 14 Art Unit: 1645 Application/Control Number: 18/027,696 Page 15 Art Unit: 1645 Application/Control Number: 18/027,696 Page 16 Art Unit: 1645 Application/Control Number: 18/027,696 Page 17 Art Unit: 1645 Application/Control Number: 18/027,696 Page 18 Art Unit: 1645
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