Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in response to applicant’s reply filed on June 16, 2026.
Restrictions/Elections.
Applicant’s election of Group I (Claims 106-118 and 120-121) in the reply filed on June 16, 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a).
Applicant election of the following diseases: chronic pancreatitis from claim 117 and small bowel syndrome form claim 118 is acknowledged. However, Applicant was required to elect a single disclosed species, not two. Further, claim 118 does not disclose “small bowel syndrome”, it discloses “inflammatory bowel disease”, “irritable bowel syndrome” and “short bowel syndrome”, but not “short bowel syndrome”, as such “chronic pancreatitis” will be considered as the only species elected.
Status of Claims
Claims 106-118 and 120-124 are currently pending and are the subject of this office action.
Claim 122-124 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 16, 2026.
Claims 118 and 120-121 are further withdrawn, since they do not encompass the elected species: “chronic pancreatitis”.
Claims 106-117 are presently under examination.
Priority
The present application is a 371 of PCT/US2022/046365 filed on 10/12/2022 and claims priority to provisional application No. 63/254,786 filed on 10/12/2021.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 106 -107, 109-110, 112, 114 and 116-117 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yesair (US 5,891,466).
For claims 106 and 116-117, Yesair teaches that fat absorption can be compromised in individuals with cystic fibrosis (see column 4, lines 8-20). As such, the inventors disclose a method of increasing fat absorption in patients with cystic fibrosis (i.e. a subject in need for increased dietary fat absorption) comprising the administration of a eutectic matrix (EM) or colloidal eutectic matrix (CEM) of lipids (see column 9, lines 12-35 and Figures 7 through 11), wherein the colloidal eutectic matrix (CEM) comprises: lysophosphatidyl choline (LPC), monoglycerides and fatty acids (see Example 3 on column 16, lines 34-39), and further comprises vitamins, sodium bicarbonate (see column 16, line 47) and calcium chloride (see column 16, line 63).
The prior art is silent regarding: “wherein the subject absorbs dietary fat from the food of beverage through MDR3 mediated recycling of LPC from the subject’s circulatory system to the digestive track”
However, “wherein the subject absorbs dietary fat from the food of beverage through MDR3 mediated recycling of LPC from the subject’s circulatory system to the digestive track”, does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises vitamins, sodium bicarbonate and calcium chloride".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “the subject absorbs dietary fat from the food of beverage through MDR3 mediated recycling of LPC from the subject’s circulatory system to the digestive track” appears to be the result of the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises vitamins, sodium bicarbonate and calcium chloride", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
For claim 107, Yesair teaches that the composition can comprise fat soluble vitamins (see column 7, lines 11-12 and lines 50-51; and column 13, line 3).
Yesair further teaches that the administration increases the absorption of fatty acids (see results and discussion on columns 18-19).
Further, “wherein the administration increases the absorption of monosaturated, polyunsaturated, and/or saturated fatty acids in the subject”, does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises vitamins, sodium bicarbonate and calcium chloride".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “an increase in the absorption of monosaturated, polyunsaturated, and/or saturated fatty acids in the subject” appears to be the result of the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises vitamins, sodium bicarbonate and calcium chloride", e. g. the intended result of a process step positively recited.
For claim 109, Yesair is silent regarding ”wherein the dietary fat absorption in the subject is increased independently of lipase activity and/or bile acid in the subject”.
However, “wherein the dietary fat absorption in the subject is increased independently of lipase activity and/or bile acid in the subject”, does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises vitamins, sodium bicarbonate and calcium chloride".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “the dietary fat absorption in the subject is increased independently of lipase activity and/or bile acid in the subject” appears to be the result of the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises vitamins, sodium bicarbonate and calcium chloride", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
For claim 110, Yesair teaches that the administration of the composition is useful for the treatment of fat-soluble vitamin deficiency in cystic fibrosis patients as well as in other disease conditions with malabsorption or malnutrition (see column 19, lines 24-29).
Further, “wherein the administration increases absorption of fat-soluble vitamins and/or antioxidants in the subject”, does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises vitamins, sodium bicarbonate and calcium chloride".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “the administration increases absorption of fat-soluble vitamins and/or antioxidants in the subject” appears to be the result of the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises vitamins, sodium bicarbonate and calcium chloride", e. g. the intended result of a process step positively recited.
For claim 112, Yesair teaches the measurement of fatty acids before and after treatment (see results and discussions on columns 18-19, see also column 9, lines 12-35 and figures 7 through 11).
For claim 114, Yesair teaches that the subjects in need thereof are humans (see Example 3 on column 16).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 108, 111, 113 and 115 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yesair (US 5,891,466).
Yesair teaches all the limitations of claim 108 (see above 102(a)(1) rejection), except for the specific fatty acids. However, linoleic acid, alpha-linolenic acid, eicosapentaenoic acid and docosahexaenoic acid are well known fatty acids, as such, before the effective filing date of the invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any fatty acid) for another (linoleic acid, alpha-linolenic acid, eicosapentaenoic acid and docosahexaenoic acid) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claims 108, with a reasonable expectation of success.
Yesair teaches all the limitations of claim 111 (see above 102(a)(1) rejection), except for the specific fat-soluble vitamins. However, vitamin A, D, E and K are well known fat-soluble vitamins, as such, before the effective filing date of the invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any fat-soluble vitamin) for another (vitamin A, D, E and/or K) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claims 111, with a reasonable expectation of success.
Yesair teaches all the limitations of claim 113 (see above 102(a)(1) rejection), except for the matrix comprising LPC being in semi-solid form. However, formulations of known pharmaceuticals, including in semi-solid forms, are well known in the art, and since formulation of known drugs is no more than routine experimentation, before the filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to formulate the composition disclosed by Yesair as a semi-solid form, thus resulting in the practice of claim 113 with a reasonable expectation of success.
Yesair teaches all the limitations of claim 115 (see above 102(a)(1) rejection), except for the subject being a non-human animal. However, as stated above, the method of Yesair is effective in humans, as such it will be expected to also be efficacious in certain non-human animals, thus resulting in the practice of claim 115 with a reasonable expectation of success.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 106-107, 109-112, 114 and 116-117 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stallings et. al. (PLOS ONE (May 2020) 1-13) as evidenced by Bertolaso et. al. (JPGN (2014) 58:443-448).
For claim 106 and 116-117, Stallings teaches (see page 1 abstract and introduction) a method of increasing fat absorption comprising administering to subjects with cystic fibrosis (i.e. a subject having a need for increased dietary fat absorption) an effective amount of EncalaTM (a mix of lypophosphatidylcholine (LPC), monoglycerides and fatty acids, see page 3 under Design). EncalaTM (previously known as LYM-X-SORBTM) also contains small amounts of vitamin E (a fat-soluble vitamin) as evidenced by Bertolaso. Bertolaso teaches that LYM-X-SORBTM contains small amounts of Vitamin E (see page 444, left column, first paragraph).
The prior art is silent regarding: “wherein the subject absorbs dietary fat from the food of beverage through MDR3 mediated recycling of LPC from the subject’s circulatory system to the digestive track”
However, “wherein the subject absorbs dietary fat from the food of beverage through MDR3 mediated recycling of LPC from the subject’s circulatory system to the digestive track”, does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises the fat soluble vitamin E".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “the subject absorbs dietary fat from the food of beverage through MDR3 mediated recycling of LPC from the subject’s circulatory system to the digestive track” appears to be the result of the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises the fat soluble vitamin E", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
For claim 107, as mentioned above Stalling as evidenced by Bertolaso teaches that the composition can comprise the fat-soluble vitamin E.
Stalling further teaches that the administration increases the absorption of fatty acids (see results on page 1).
Further, “wherein the administration increases the absorption of monosaturated, polyunsaturated, and/or saturated fatty acids in the subject”, does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises the fat soluble vitamin E ".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “an increase in the absorption of monosaturated, polyunsaturated, and/or saturated fatty acids in the subject” appears to be the result of the process anticipated by the prior art: “a method of increasing dietary fat absorption comprising the administration to a subject in need thereof of a composition comprising: lysophosphatidyl choline (LPC), monoglycerides, fatty acids and further comprises the fat soluble vitamin E", e. g. the intended result of a process step positively recited.
For claim 109, Stallings further teaches that the method does not require lipase activity for digestion (see page 3 under design).
For claim 110, Stallings teaches an increase in the absorption of fat-soluble vitamins (see page 5, paragraph below the table, see also page 8, second paragraph).
For claim 111, as stated above, EncalaTM (previously known as LYM-X-SORBTM) also contains small amounts of vitamin E (a fat-soluble vitamin) as evidenced by Bertolaso. Bertolaso teaches that LYM-X-SORBTM contains small amounts of Vitamin E (see page 444, left column, first paragraph).
For claim 112, Stalling teaches determining the level of fatty acids before and after administration of EncalaTM (see page 5 under Results, Table 2).
For claim 114, Stallings teaches that the subject is an infant (see title for example).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 108, 113 and 115 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stallings et. al. (PLOS ONE (May 2020) 1-13) as evidenced by Bertolaso et. al. (JPGN (2014) 58:443-448).
Stallings, as evidenced by Bertolaso, teaches all the limitations of claim 108 (see above 102(a)(1) rejection), except for the specific fatty acids. However, linoleic acid, alpha-linolenic acid, eicosapentaenoic acid and docosahexaenoic acid are well known fatty acids, as such, before the effective filing date of the invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any fatty acid) for another (linoleic acid, alpha-linolenic acid, eicosapentaenoic acid and docosahexaenoic acid) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claims 108, with a reasonable expectation of success.
Stallings, as evidenced by Bertolaso, teaches all the limitations of claim 113 (see above 102(a)(1) rejection), except for the matrix comprising LPC being in semi-solid form. However, formulations of known pharmaceuticals, including in semi-solid forms, are well known in the art, and since formulation of known drugs is no more than routine experimentation, before the filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to formulate the composition disclosed by Yesair as a semi-solid form, thus resulting in the practice of claim 113 with a reasonable expectation of success.
Stallings, as evidenced by Bertolaso, teaches all the limitations of claim 115 (see above 102(a)(1) rejection), except for the subject being a non-human animal. However, as stated above, the method of Yesair is effective in humans, as such it will be expected to also be efficacious in certain non-human animals, thus resulting in the practice of claim 115 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
June 17, 2026.
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