Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Application, Amendments and/or Claims
2. The preliminary amendment of 2/12/2026 is acknowledged. Claim 63 has been cancelled. Claims 60, 64, 75 and 76 have been amended. Claims 60-62 and 64-76 are currently pending.
Rejection withdrawn
3. Upon consideration of appropriate amendment of claim 76, the rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement, is withdrawn.
Rejections maintained
Claim Rejections - 35 USC § 103
4. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
5 Claims 60-62, 64-65 and 67-76 are rejected under 35 U.S.C. 103(a) as being unpatentable over Lee et al (US PGPB number 20040121002, dated 24 June 2004) in view of Ortenzi et al. (US Patent number 8221747, filed 2/20/08), and further in view of Fallon US 6632429 (10/14/2003) (all listed in IDS), as evident from Sinzig et al (2008). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
6. The claims are directed to a method of treating Autism and Autism spectrum disorder (ASD) in subject comprising administering a composition comprising coated particles comprising a core comprising digestive enzymes (protease, amylase and lipase) that are present in about 75 to about 85% (75%, 77.5%, 80%, 82.5%, 85%) by weight of the particles, and a coating comprising a food grade lipid (hydrogenated soy oil, sorbitan monostearates or tristearates, calcium stearoyl lactylate), wherein the digestive enzymes are derived from porcine pancreas (claims 60-61, 64-65, 70-76). The claims also recite that the composition is non-aerosolizable (claim 67), is provided as pancreatin (claim 68) and is in a sachet or pouch (claim 69). The claims further recite that the composition has a protease, amylase and lipase activity of not less than 156, 25 and 2 U.S.P. units/mg respectively, and no more than 6% fat and 5% loss on drying, and is negative for the recited bacterial species (claim 62).
7. Lee et al teach "an encapsulated bioactive substance composite" (para 0021), comprising a core containing a bioactive substance such as enzymes like lipase or 7amylase (well known as digestive enzymes), pectinase (protease) (para 0022, 0034), and a coating comprising an emulsifiable lipid (para 0022), wherein the enzyme is present in the preparation having a preferred concentration of the bioactive substance of between 50% and 95% of the encapsulated composite, i.e. encompass about 75% to about 85% by weight of the particles (para 0039). Lee et al teach that the emulsifiable lipid is food grade, of the like of sorbitan monostearates or tristearates, calcium stearoyl lactylate, soybean (soy) oil, which is preferably hydrogenated, etc. (para 0044, 0049). The reference teaches that the compositions can help nutritional deficiencies and thereby provide a health benefit (para 0035). (instant claims 60, 64-65, 70-74).
8. Lee et al do not teach the different enzyme activities recited in claim 62.
9. Ortenzi et al teach treating a disorder associated with digestive enzyme deficiency, comprising administering the digestive enzyme composition to a mammal or human subject (Abstract; col 15, lines 7-11). The reference teaches pancrelipase (pancreatin) (combination of amylase, lipase and protease) compositions having an enzyme core, wherein the total amount of enzymes by weight is about 70%, 80%, 90% etc. effective for treating digestive enzyme deficiencies (abstract; col 3, lines 16-17, 36-38; col 5, lines 51-55) (instant claims 60, 68, 70-74). The reference also teaches that the digestive enzyme is a pancreatic extract from porcine, wherein the composition has a protease activity of greater than or equal to 264 U USP/mg; amylase activity greater than or equal to 216 U USP/mg; lipase activity of 69-120 U USP/mg (i.e. not less than the activities recited in instant claim 62) (col 4, para 5), and wherein the composition can be provided in the form of tablets (non-aerosolizable) or sachets (col 9, lines 60-61) (instant claims 61, 62, 67, 69). Even though Ortenzi et al teach pancreatin/pancrelipase, the reference does not mention the characteristics of the composition as recited in parts (d), (e) of claim 62, and absence of the bacterial species (instant claim 62). However, these would be inherent features of pancreatin/pancrelipase as also evidenced in para 0149 and Table 6 of the instant specification. It is understood that “a compound and all of its properties are inseparable” In re Papesch, CCPA 137, USPQ 43.
10. Lee et al, or Ortenzi et al do not teach that the enzyme composition is used for treating Autism, or autism spectrum disorder.
11. Fallon teaches treating autism, ADD, ADHD, PDD, with digestive enzyme administration (Abstract). As stated above, the prior art indicates that ADHD/ADD is comorbid with autism (Sinzig et al; Abstract). Fallon also teaches that subjects having autism suffer from GI problems like constipation and diarrhea (col 1, lines 37-40). Fallon further teaches a method of treating protein digestion deficiency and bowel movement abnormalities in autism (GI symptoms associated with autistic disorder) comprising administering digestive or pancreatic enzymes comprising protease, amylase and lipase (claims 1, 4, 13, 14; col 10, lines 31-33; Experiment 6), thereby treating the GI symptoms (Tables 5, 6). The reference teaches treating ADD and ADHD patients having pathological or sub-normal (abnormally low) FCT levels comprising administering the enzyme preparation (Examples 3, 4). The reference also teaches that the pancreatic enzyme extract is pancreatin (col 10, line 43) (instant claims 75, 76).
12. It would have been, therefore, obvious to the person of ordinary skill in the art at the time the claimed invention was made to modify the method of treating a digestive enzyme deficiency comprising administration of a digestive enzyme composition comprising protease, amylase and lipase with core and coating specifics as taught by the combined teachings of Lee et al and Ortenzi et al by treating autism and ASD associated co-morbidity like ADD, ADHD and PDD having sub-normal FCT levels, wherein autism has gastrointestinal symptoms in view of the teachings of Fallon. The person of ordinary skill in the art would have been motivated to make the modification as subjects having autism suffer from gastrointestinal problems like constipation and diarrhea, i.e. abnormal bowel movement which can be treated by administration of the enzyme composition (Fallon). The person of ordinary skill in the art would also have been motivated to test FCT levels in autistic or ADD/ADHD/PDD individuals, as this would help in determining abnormal protein digestion and the benefit of treatment with enzymes (col 2, Summary of the Invention – para 1-4). The person of ordinary skill would have expected success as enzyme supplementation was considered as a corrective option in many disorders like autism at the time the invention was made.
13. Thus, the claimed invention as a whole was prima facie obvious over the combined teachings of the prior art.
14. Claims 60-62 and 64-76, are rejected under 35 U.S.C. 103(a) as being unpatentable over Lee et al. (2004) and Ortenzi (2008) in view of Fallon (2003), and in further view of Sipos et al. (US Patent number 5324514, dated 28 June 1994 – listed in IDS). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
15. Claim 66 recites that the core is from about 105µm to about 425 µm.
16. The teachings of Lee et al, Ortenzi et al and Fallon are set forth above.
17. Lee et al, Ortenzi et al or Fallon do not teach the core specifics.
18. Sipos teaches a 'digestive enzyme" composition (col 4, lines 62-63), prepared by techniques including extrusion for treating pancreatic enzyme deficiency and other related disorders (col 1, para 2; col 6, last para). Sipos also teaches the use of standard sieve screens for the formation of different size particles, such as 80 mesh particles, or 80 mesh microspheres (col 7, line 67, 44, 45), equivalent to 177 microns (about 105 to 425 µm), which are especially beneficial for use to treat pancreatic enzyme deficiency disorders (col 4, lines 24-27).
19. It would have therefore been obvious to the person of ordinary skill in the art at the time the claimed invention was made to modify the method of treating autism, ASD, comorbidity and GI symptoms thereof, comprising administering a digestive enzyme composition as taught by the combined teachings of Lee et al, Ortenzi et al, and Fallon, wherein the digestive enzyme has specific core size in view of Sipos. The person of ordinary skill in the art would have been motivated to make the modification, because adjusting the dimensions of the core or sphere would enable ease of administration of the enzyme (Sipos, col 11, para 2). The person of ordinary skill would have expected success because research involving the improved rate of release of therapeutics was an ongoing endeavor for drug development at the time the invention was made.
20. Thus, the claimed invention as a whole was prima facie obvious over the combined teachings of the prior art.
Applicant’s Remarks:
21. Applicant alleges that the combination of cited art fails to teach all the claimed elements. Applicant argues that Lee teaches encapsulated yeast compositions, which is different from instantly claimed digestive enzyme composition. Applicant emphasizes that different coatings will present different characteristics like dissolution of the enzymes. Applicant argues that Ortenzi teaches an enteric coating comprising at least “one enteric polymer”, which is not favored in the instant specification (Study 7, Table 14). Applicant also argues that based upon Table 14, FCT levels of autistic children provided with enteric coated Ultrase or raw Viokase powder, showed that Ultrase did not provide a significant change in FCT levels. Applicant further argues that Sipos teaches polymer coated digestive enzymes for treating digestive disorders, which is different from instant enzyme preparation.
22. Directing to the teachings in the instant specification, Applicant asserts that Example 6 and Table 4 demonstrate that the taste and smell masking property is not shown by all lipid coatings, and that lipid coated preparations with 90% enzymes had a slight odor and salty taste. Applicant also asserts (Figure 5 of the specification) that the 80% enzyme preparation had an unexpectedly “superior enzyme release properties” than the 70% or 90% enzyme preparations. Pointing to Example 9 of the specification, Applicant states that the maximum release rate “for the 90%, 80% and 70% particles was 85%, 88% and 83% respectively”. Applicant therefore, concludes that preparations comprising digestive enzymes in “an amount of about 80% (from about 75% to about 85%) ….is unexpectedly better than coated particles with a higher or lower percent of digestive enzymes” which could not be predicted at the time of filing of the instant application.
23. Applicant submits a Statement of Results (pages 10-12 of Remarks) based upon an ongoing clinical trial, wherein subjects with autism were administered with the instantly claimed coated digestive enzyme preparation (Formulation 1), or placebo for 90 days, and wherein the behavior was assessed using the ABC scale. Applicant concludes that Formulation 1 shows statistically significant improvement (including ABC irritability score) over placebo. Applicant adds that the “present application represents an improvement over the disclosure of Fallon” and alleges that the “rejection is impermissibly based on hindsight reasoning”.
24. Applicant therefore, requests withdrawal of 103 rejections.
25. Applicant’s argument about individual references is considered, however, are not found to be persuasive. Applicant’s argument that Lee teaches encapsulated yeast compositions is considered. However, as stated in the rejection, Lee et al teach other bioactive substances like enzyme compositions comprising a core having 50-95% of the encapsulated composite and a food grade lipid coating comprising soybean oil, wherein such compositions can provide health benefits. Applicant’s attacking Ortenzi art for teaching enteric coating is not persuasive, as Ortenzi was primarily used for teaching the enzyme activity elements of claim 62. Likewise, Applicant’s argument against Sipos teaching polymer coated digestive enzymes is not persuasive, as the reference was only used to teach core size of the digestive enzyme particles. Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
26. Applicant’s argument that Ortenzi teaches enteric coating which is not favored based upon results presented in Table 14 of instant specification has been considered but is not found to be persuasive. In the table (Study 7), mean FCT levels were measured until 120 days after administration of enteric coated Ultrase, or raw powder Viokase (not coated) to autistic children. FCT levels increased in both treated groups, even though the increase with Viokase was more notable and significant. The comparison however, does not appear to be reasonably commensurate with the instant claimed requirements. Even though Viokase is not enteric coated, Viokase is also not food grade lipid coated (according to instant claims). Rather, Viokase is only in raw powder form, i.e. uncoated. It is known that any coating can delay dissolution and release of active ingredient resulting in a slower onset of action.
27. Applicant’s arguments directed to specific examples, table and figures of the instant specification to show unexpected results are fully considered, however, are not found to be persuasive.
28. With regards to the masking of odor and taste property of different percent of enzyme preparations, encapsulated 90% enzyme by weight showed a slight odor and salty taste. Example 6 does not, however, state that the masking is dependent on lipid coatings as indicated by Applicant stating “This result demonstrates that not all lipid coatings have the property of masking the taste and smell…”. Also, instant claims do not require “masking the taste and smell”. Applicant’s arguments relying on particular distinguishing features are not persuasive when those features are not recited in the claims. Narrow limitation contained in the specification cannot be inferred in the claims where the elements not set forth in the claims are linchpin of patentability. See In re Philips Industries, Inc. v. State Stove & Mfg. Co., 522 F.2d 1137, 186 USPQ 458 (CA6 1975), 237 PTJA A-12. While the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992). Applicant is reminded that the claims define the subject matter of his invention and that the specification cannot be relied upon to read limitations into the claims.
29. Applicant’s argument pertaining to Figure 5 (Example 4) or Example 9, asserting unexpectedly “superior enzyme release properties” of the 80% enzyme preparation is considered and is not found to be persuasive. The last paragraph of Example 4 states that all encapsulates (70%, 80% and 90% of enzyme) showed between 80-90% enzyme release at 30 and 60 minutes (Figure 5). It is, however, not clear if the percent release of the three enzyme preparations of Figure 5 are significantly different from one another. More importantly, it is not convincing from Figure 5 or Example 9, that the 80% enzyme preparation had unexpectedly “superior enzyme release properties” over those of the 70% or 90% enzyme preparations. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) MPEP 716.02(b)(I). Applicant’s assertion that preparations comprising digestive enzymes in “an amount of about 80% (from about 75% to about 85%) ….is unexpectedly better than coated particles with a higher or lower percent of digestive enzymes” is therefore not persuasive.
30. The Statement of Results using Formulation 1 (instantly coated digestive enzyme preparation) is fully considered. It is noted that Formulation 1 is only compared to placebo, and not to other forms of enzyme preparations with different coatings (e.g. lipid, or enteric). The prior art acknowledges the fact that digestive preparations comprising the three claimed enzymes were known to treat autism. As stated in the rejection, Fallon teaches treating 17 autistic children by administering the enzyme preparation, resulting in a “notable decrease in autistic symptomotology of each of the 17 autistic children” (Experiment 6; Table 5, 6; col 10, lines 58, 59), and an increase of FCT levels to normal range (Table 4; col 10, lines 51-57). Since Fallon also teaches notable improvements in behavior and FCT levels using a preparation comprising the digestive enzymes of present claims, the “improvement” asserted by Applicant would obviously be expected.
31. Applicants may argue that the examiner's conclusion of obviousness is based on improper hindsight reasoning. However, "[a]ny judgement on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper." In re McLaughlin 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).
32. The combination of the above references proves that the knowledge and expertise for the claimed method for treating autism, ASD or co-morbidity associated with ASD in a subject, comprising administration a digestive enzyme composition comprising a core and a food grade lipid coating, was known in the art and the results were expected to be successful. The prima facie obviousness of the claimed invention in view of the combined references, therefore, provides sufficient reasoning, and nullifies Applicant’s allegations of the improper teachings in the individual references. Applicant’s assertion of unexpected results does not overcome the rejection because of obvious expected properties taught in the prior art, either explicitly or implicitly. “Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness”. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977). That is, the alleged unexpected results are actually expected from the prior art.
33. In view of the foregoing reasoning, the 103 rejections are maintained.
Double Patenting
34. 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).
35. 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 §§ 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.
36. Please visit www.uspto.gov/patent/patents-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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
NOTE: The provisional rejection over application 16/983352 is withdrawn, as the application is now abandoned.
37. Claims 60-62, 64-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-26 of US patent 11,419,821. The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims recite an enzyme composition comprising a core of digestive enzyme particles in an amount from about 75-85% by weight, and a coating of emulsifiable lipid, OR recite a method of treating subjects with autism/ASD by administering the enzyme composition. That is the composition claims of '821 patent implicitly carry the intended use of a method for treating autism/ASD using said composition, as recited in the instant method claims. The ‘821 patent even teaches treating the same diseases as instantly recited by administration of said digestive enzymes (for example, col 35, Example 12). As the ‘821 claims recite the enzyme composition having the same utility as claimed in the method of instant claims, the claims are not patentably distinct. The situation is comparable to the Sun Pharmaceutical Industries, Ltd v. Eli Lilly and Company 2010 court case, where it was concluded that double patenting is valid in a patent claiming the method using a compound over a patent claiming the compound having same utility described in specification. It is also noted that the present case was filed as a CON of the ‘821 patent, not a DIV. As it is a CON it is not protected from double-patenting rejections. See Amgen v Hoffman LaRoche, 92 USPQ2d 1289; 580 F3d 1340.
[We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application. See Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir. 1990) (“To gain the benefits of Section 121 there outlined, [the patentee] must have brought its case within the purview of the statute, i.e., it must have limited the claims in its divisional application to the non-elected invention or inventions.” (emphasis added)). We recognize that, unlike a continuation-in-part application, a continuation application can satisfy the definition of a “divisional application” in MPEP § 201.06. That is because a continuation-in-part application adds subject matter not disclosed in the earlier application, see MPEP § 201.08, whereas continuation and divisional applications are limited to subject matter disclosed in the earlier application, see MPEP §§ 201.06, 201.07. This distinction, however, does not justify departing from a strict application of the plain language of § 121, which affords its benefits to “divisional application[s].” See 35 U.S.C. § 121 (sheltering from attack “a divisional application divisional application is filed before the issuance of the patent on the other application” (emphases added)); see also Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382 (Fed. Cir. 2003) (“Given the potential windfall [a] patent term extension could provide to a patentee, this court applies a strict test for application of § 121.”]
38. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 11,419,821.
It is suggested that the ODP rejection can be withdrawn by either filing a terminal disclaimer or changing the status of the instant application from a CON to a DIV.
39. Claims 60-62, 64-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-44 of U.S. Patent No. 9,056,050, issued Jun 16, 2015. The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating a subject with ASD comprising administering a composition comprising a core comprising digestive enzymes protease, amylase and lipase and a coating comprising emulsifiable lipid, wherein the digestive enzymes are present in an amount from about 75-85% (or 77.5-82.5%) by weight.
Instant claims are therefore, anticipated by the ‘050 patent claims.
40. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 9,056,050.
41. Claims 60-62, 64-76, are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of US Patent No. 6,632,429 issued 14 October 2003 in view of Lee et al (2004), Ortenzi et al (2008) and Sipos (1994). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are drawn to a method of treating autism in a subject comprising administering digestive enzymes.
The only differences are as follows:
(i) Instant claims recite digestive enzymes comprise protease, amylase and lipase, while ‘429 claims do not recite specific enzymes. However, this would be obvious in view of the ‘429 specification teaching treating autistic children with digestive/pancreatic enzymes comprising amylase, protease and lipase (Experiment 6, col 10, lines 31-33).
ii) Instant claims recite the composition specification, while ‘429 patent claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee et al, Ortenzi et al and Sipos for reasons stated above.
42. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 6,632,429.
43. Claims 60-62, 64-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12, 23-31, 37-71 of U.S. Patent No. 8,163,278, issued 24 April 2012 in view of Lee et al (2004), Ortenzi et al (2008) and Sipos (1994). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating autism (or autism symptom) in a subject/individual comprising administering digestive enzymes comprising protease, amylase and lipase.
The only difference is as follows:
Instant claims recite the composition specification, while ‘278 patent claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee et al, Ortenzi et al and Sipos for reasons stated above.
44. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,163,278.
45. Claims 60-62, 64-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 5-7 of U.S. Patent No. 8,012,930, issued 6 September 2011 in view of Lee et al (2004), Ortenzi et al (2008) and Sipos (1994). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating a subject/individual comprising administering digestive enzymes comprising protease, amylase and lipase.
The only differences are as follows:
i) Instant claims recite treating autism, while ‘930 claims recite treating ADD/ADHD. However, the ‘930 PGPB teaches that autism, ADD and ADHD are PDDs and all can individually be treated with amylase, protease and lipase (para 0003, 0054, 0063), wherein PDD is an autism spectrum disorder (as taught in para 0037 of the instant PGPB).
ii) Instant claims recite the composition specification, while ‘930 patent claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee et al, Ortenzi et al and Sipos for reasons stated above.
46. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,012,930.
47. Claims 60-62, 64-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 8,105,584, issued 31 January 2012 in view of Lee et al (2004), Ortenzi et al (2008) and Sipos (1994). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating a subject/individual comprising administering digestive enzymes comprising protease, amylase and lipase.
The only differences are as follows:
i) Instant claims recite treating autism/ASD, while the ‘584 claims recite treating ADD/ADHD. However, the ‘584 PGPB teaches that autism, ADD and ADHD are PDDs, and all can individually be treated with amylase, protease and lipase (para 0005, 0052, 0057, 0061), wherein PDD is an autism spectrum disorder as taught in para 0037 of the instant PGPB.
ii) Instant claims recite the composition specification, while ‘584 patent claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee et al, Ortenzi et al and Sipos for reasons stated above.
48. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,105,584.
49. Claims 60-62, 64-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 8,008,036, issued 30 August 2011 in view of Lee et al (2004), Ortenzi et al (2008), Sipos (1994) and Fallon US 6632429 (2003). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims recite treatment of autism in a person (subject) with digestive enzymes.
The only differences are as follows:
i) Even though ‘036 patent claims mention treating a subject diagnosed with autism as being a candidate for treatment with digestive enzymes, the claims do not recite the step of administering digestive enzymes as present in instant claims. However, since the ‘036 patent claims recite that upon identifying the person with autism, the person will be a candidate for treatment with the enzymes, it would obviously imply that upon identification, the person will be treated by administration of digestive enzymes.
The only differences are as follows:
i)Instant claims recite digestive enzymes amylase, protease and lipase, while ‘036 claims do not have this limitation. However, this would be obvious in view of the ‘036 PGPB teaching treatment of autistic children with digestive/pancreatic enzymes comprising amylase, protease and lipase (Experiment 6, para 0063). This is also obvious over the teachings of Fallon ‘429 (Experiment 6).
ii) Instant claims recite the composition specification, while ‘036 claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee et al, Ortenzi et al and Sipos as stated above.
iii) Instant claims do not recite a step of identifying a person diagnosed with autism as being a candidate for digestive enzyme therapy, which is present in the ‘036 claims. However, this would be an obvious step to determine the effect of digestive enzymes based upon the teachings of Fallon ‘429 (Experiment 6).
50. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,008,036.
51. Claims 60-62, 64-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,624,526, issued 18 April 2017 in view of Lee et al (2004), Ortenzi et al (2008), Sipos (1994). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating autism or autistic disorder in a subject/individual comprising administering digestive enzymes comprising protease, amylase and lipase.
The only difference is as follows:
Instant claims recite the composition specification, while ‘526 patent claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee et al, Ortenzi et al and Sipos for reasons stated above.
52. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 9,624,526.
53. Claims 60-62, 64-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 9,624,525, issued 18 April 2017 in view of Lee et al (2004), Ortenzi et al (2008), Sipos (1994) and Fallon ‘429 (2003). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating PDD (an ASD based upon teaching in para 0037 of the instant PGPB) in a subject/individual comprising administering digestive enzymes comprising protease, amylase and lipase. It is also noted that PDD spectrum includes autism (‘525 patent, col 1, lines 37-38).
The only differences are as follows:
i) Instant claims recite the composition specification, while ‘525 patent claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee et al, Ortenzi et al and Sipos for reasons stated above.
ii) ‘525 claims recite pre- and post-administration measurements of fecal chymotrypsin, while instant claims are silent on this limitation. However, this would be obvious in view of the teachings of Fallon ‘429. The reference teaches treatment of autistic children comprising administration of digestive enzymes, wherein fecal chymotrypsin levels were measured before and after enzyme administration to determine the effect of enzyme therapy (Experiment 6).
54. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 9,624,525.
55. Claims 60-62, 64-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8,815,233, issued 26 August 2014 in view of Lee et al (2004), Ortenzi et al (2008), Sipos (1994). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating PDD (an ASD based upon teaching in para 0037 of the instant PGPB) or autism in a subject/individual comprising administering digestive enzymes comprising protease, amylase and lipase.
The only difference is as follows:
Instant claims recite the composition specification, while ‘233 patent claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee et al, Ortenzi et al and Sipos for reasons stated above.
56. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,815,233.
57. Claims 60-62, 64-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 8,613,918, issued 24 Dec 2013 in view of Lee et al (2004), Ortenzi et al (2008), Sipos (1994) and Fallon ‘429 (2003). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205. Please note that previously rejected claim 63 has now been canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating PDD (an ASD based upon teaching in para 0037 of the instant PGPB) or autism in a subject/individual comprising administering digestive enzymes comprising protease, amylase and lipase.
The only differences are as follows:
i) Instant claims recite the composition specification, while ‘918 patent claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee et al, Ortenzi et al and Sipos for reasons stated above.
ii) ‘918 claims recite measurement of fecal chymotrypsin before enzyme administration, while instant claims are silent on this limitation. However, this would be obvious in view of the teachings of Fallon ‘429. The reference teaches treatment of autistic children comprising administration of digestive enzymes, wherein fecal chymotrypsin levels were measured before and after enzyme administration to determine the effect of enzyme therapy (Experiment 6). The reference also teaches that fecal chymotrypsin levels were sub-normal or pathologic in the autistic children included for treatment (Table 4).
58. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 8,613,918.
59. Claims 75-76 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 9,687,452, in view of Sinzig et al (2008) and Fallon ‘429 (2003). The rejection is maintained for reasons of record in the Office Action dated 8/14/20205.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are directed to a method of treating a co-morbidity associated with ASD (ADD) in a subject comprising administering digestive enzymes comprising protease, amylase and lipase.
The only difference is as follows:
‘452 claims recite treating ADD, while instant claims recite treating autism or ASD. However, it would obvious to treat ADD/ADHD with the enzyme composition as these are known to be comorbid conditions associated with ASD as taught by Sinzig et al (see para 20 above). It would also be obvious to treat ADD subjects with the enzyme composition because of the presence of abnormal FCT levels in these subjects (Fallon ‘429, Experiment 3).
60. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 9,687,452.
Note: It is incumbent on the Applicant to inform the office of all related subject matter and to file all related terminal disclaimers. See 37 CFR 1.56, Duty to disclose information material to patentability.
Applicant’s Remarks:
61. Applicant argues each of the double patenting rejections on an individual basis. The common points of argument are summarized as follows:
i) Instant claims recite food grade lipid coating comprising soy oil, while patent claims (patent number ‘050) require an emulsifiable lipid coating that masks the taste and smell of the enzymes.
ii) Conflicting patent (e.g. patent numbers ‘429, ‘930, ‘036, ‘918) claims require additional method steps, that are not present in instant claims.
iii) Conflicting patent (e.g. patent numbers ‘278, 930, ‘526, ‘525, ‘233, ‘918) claims do not recite the instant particle and coating specifications and the deficiencies of Lee, Ortenzi and Sipos are discussed above.
iv) Arguing patent claims (of patent numbers ‘930, ‘584 and ‘452), Applicant asserts that ADD and ADHD are different from autism.
62. Applicant’s arguments are fully considered, however, are not found to be persuasive for reasons explained below.
i) It is noted that claim 6 of the '050 patent recites that the emulsifiable lipid is hydrogenated soy oil. Also, para 0094 of the instant specification teaches that an emulsifiable lipid can be derived from soybean oil. Additionally, based upon Applicant’s remarks (page 8, para 1), the lipid coating of the instant claims was intended to mask the taste and smell of the digestive enzymes. The emulsifiable lipid coating of ‘050 claims, is therefore, construed to be identical to the instantly recited food grade lipid coating, absent any evidence to the contrary.
ii) With regards to Applicant’s argument that the stated patent claims require additional method steps that are absent in instant claims, it is noted that instant claims recite a method “comprising…”. The MPEP states that “comprising” is a transitional term, which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). ("The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.") [MPEP 2111.03(I)].
iii) Even though the patent (‘278, 930, ‘526, ‘525, ‘233, ‘918) claims do not recite the instant particle and coating specifications, it is repeated that these would be obvious in view of the combined teachings of Lee, Ortenzi and Sipos for reasons stated above.
iv) Applicant’s argument that ADD and ADHD are different from ASD or autism is considered. However, as stated above, the ‘930 PGPB teaches that autism, ADD and ADHD are PDDs and all can individually be treated with amylase, protease and lipase (para 0003, 0054, 0063), wherein PDD is an autism spectrum disorder (as taught in para 0037 of the instant PGPB).
New Double Patenting rejections
63. NOTE: The following provisional rejections are made over co-pending applications that were filed after the notification date (8/14/2025) of the last Office action.
64. Claims 60-62 and 64-76 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 27 and 58 of co-pending application number 19/335,455 (filed 9/22/2025), in view of Lee et al (2004), Ortenzi et al (2008), Sipos (1994).
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are drawn to treating a mental health disorder comprising administering digestive enzymes comprising protease, lipase and amylase (see claim 8 of ‘455 app), wherein the subject to be treated has low FCT levels.
The only differences are as follows:
(i) Instant claims recite treating autism, while ‘455 claims recite treating obsessive compulsive disorder (OCD) as one of the mental disorders. However, the instant specification (para 00188) teaches that OCD is an undesirable behavior of autism.
ii) Claim 27 of the ‘455 application recites a step of identifying a patient for treatment after determining FCT levels, while instant claims do not have this limitation. This would however, be obvious as the instant specification contemplates this step for determining abnormally low levels of fecal chymotrypsin (FCT) levels as a biomarker for autism (para 00155; Table 13).
iii) Instant claims recite the composition specification, while ‘455 claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee, Ortenzi and Sipos for reasons stated above.
65. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
66. Claims 60-62 and 64-76 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-235 of co-pending application number 19/392,513 (filed 11/18/2025), in view of Lee et al (2004), Ortenzi et al (2008), Sipos (1994), and Fallon ‘429 (2003).
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims are drawn to treating autism, autism spectrum disorder or ADD/ADHD (co-morbidity associated with ASD) in a subject comprising administering a composition comprising digestive enzymes comprising protease, amylase and a lipase, wherein the subject has abnormal FCT levels, and wherein the treatment reduces the severity of one or more symptoms.
The only differences are as follows:
i) Instant claims recite the composition specification, while ‘513 claims do not have specific core and coating limitations. However, this would be obvious in view of the teachings of Lee, Ortenzi and Sipos for reasons stated above.
ii) Instant claim 75 recites treating GI symptoms associated with ASD, while the ‘513 claims do not specifically recite GI symptoms. However, this would be obvious in view of the teachings of Fallon as stated above.
67. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
68. No claims are allowed.
69. 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).
70. 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 extension fee 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.
71. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aditi Dutt whose telephone number is (571)272-9037. The examiner can normally be reached on M-F 9:00am-5:00pm.
72. 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.
73. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker, can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
74. 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.
/A. D./
Examiner, Art Unit 1675
30 May 2026
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675
Prosecution Insights