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 responsive to the Response to Election/Restriction and Amendment filed 05/11/2026, wherein claims 3-5, 8, 13, and 19 were amended.
Claims 3-9, 13, and 19 are pending.
Note: Claim 3’s status identifier “(Previously Presented),” is incorrect. Since claim 3 is amended, the status identifier should recite “(Amended).” See MPEP 714.II.C. In view of compact prosecution, claim 3 is interpreted as amended.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of Group I, the product/pharmaceutical composition, and chenodeoxycholic acid as the serine protease inhibitor, and insulin as the therapeutic compound, in the reply filed on 05/11/2026, is acknowledged.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 3-9 and 19 are examined on the merits herein.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-9 and 19 are rejected 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-In claim 3, “(a),” “the compound which inhibits a serine protease,” renders the claim indefinite because the scope of these compounds is unclear. The phrase “selected from the group comprising,” is not proper Markush language since a Markush group is a closed group and the term “comprising” is an open-ended term that does not exclude additional elements.
Further, it is not clear if trypsin, chromotrypsin, elastase, dipenptidyl peptidase, EDTA, EGTA, chenodeoxycholate and/or propyl gallate are each a possible “compound which inhibits a serine protease,” or if “the compound which inhibits a serine protease” is trypsin, chromotrypsin, elastase, or dipenptidyl peptidase, and EDTA or EGTA, and chenodeoxycholate or propyl gallate.
For the purpose of applying prior art, “(a)” is interpreted as “a compound which inhibits a serine protease is selected from trypsin, chymotrypsin, elastase, dipeptidyl peptidase, EDTA, EGTA, chenodeoxycholate, propyl gallate, and combinations thereof,” since each of these compounds is taught by the instant specification as “a compound which inhibits a serine protease,” and since the Response to the Election/Restriction elected chenodeoxycholate as the “compound which inhibits a serine protease.”
-The scope of “therapeutic compound” in claim 6 renders the claim indefinite, as it is not clear which compounds are therapeutic compounds, and which compounds are exemplary of the therapeutic compounds; the terms, “including,” "such as," “especially,” “eg,” and “preferred,” recited throughout the claim, render the claim indefinite because it is unclear whether the limitations following these terms are part of the claimed invention or merely exemplary of the claimed invention. See MPEP § 2173.05(d).
Further, claim 6 uses both semicolons and commas to separate compounds, and it is not clear if the semicolons and commas are synonymous, i.e., used interchangeably, or if they have different meanings, and connote different groupings of “therapeutic compounds.”
Additionally, it appears that claim 6 might be referencing a Markush group of “therapeutic compounds,” but line 2 of the claim recites “selected from the group comprising.” Since a Markush group is a closed group, the term “comprising” is improper since “comprising” is an open-ended term that does not exclude additional components. See MPEP 2173.05(h) for guidance on proper Markush language.
Further, claim 6 contains at least three periods and three full sentences, wherein the periods are at the end of the claim, in line 26, and in line 29. It is not clear how sentences two and three related to the “the therapeutic compound,” recited in lines 1-2 of the claim.
Each claim must begin with a capital letter and end with a period. Periods may not be used elsewhere in the claims except for abbreviations. See MPEP 608.01(m).
For the purpose of applying prior art, sentences two and three are interpreted as not further limiting claim 6, and the recitations following the terms “including,” "such as," “especially,” eg,” and “preferred,” are interpreted as not further limiting the claim.
-Claim 7 is indefinite. Since claim 1 already recites chenodeoxycholate and/or propyl gallate as a compound which inhibits serine protease, it is unclear how claim 7 further comprises chenodeoxycholate and/or propyl gallate, especially since Applicant elected chenodeoxycholate a the species of “a compound which inhibits serine protease.”
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 does not recite further limitations of claim 3, but repeats the limitations of claim 3. As such, claim 5 fails to further limit the subject matter of claim 3.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 3, 5-6, 8-9, and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 5,653,987 to Modi (published 1997, PTO-892).
Modi teaches a liquid pharmaceutical agent formulation comprising a proteinic pharmaceutical agent and at least two absorption enhancing compounds, wherein chenodeoxycholate is such as such a compound (Cols. 7-8, Claims 1-2).
Modi teaches the proteinic pharmaceutical agent as insulin (Cols. 8-9, claims 9-10).
Regarding claims 3, 5-6, and 19, Modi exemplifies a composition comprising chenodeoxycholate, sodium chloride, and insulin (Cols. 4-5, Example 1), and teaches chenodeoxycholate as a most preferred enhancing compound (Col. 3, lines 5-10).
Further regarding claim 3, since Modi teaches a composition comprising chenodeoxycholate and insulin, the composition of Modi is prepared for simultaneous delivery to a subject.
The following are intended use recitations:
-claim 3, last two lines, and claim 5, last 3 lines, “for the treatment of a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject,”
-claim 8, line 2, “wherein the product is delivered to the gut,”
-claim 9, lines 2-end, “wherein (i) the compound is present in the intestine in a concentration of between 0.10 to 10 mg/ml. . .(iv) the compound is present in the intestine in a concentration of between 0.2 to 1 mg/ml.”
The instant claims are product claims and not method of use claims. Since the composition of Modi is capable of performing the intended use, it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
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 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.
Claims 3-9, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 5,653,987 to Modi (published 1997, PTO-892).
Modi is applied to claims 3, 5-6, 8-9, and 19, as discussed above, and incorporated herein.
Regarding claim 4, Modi does not teach a calcium or magnesium salt of chenodeoxycholate, the compound which inhibits a serine protease.
As discussed above, Modi exemplifies a composition comprising chenodeoxycholate and sodium chloride, and further teaches that for insulin-containing compounds, it is preferred that the composition also contains at least one inorganic salt which opens channels in the gastrointestinal tract and provides additional stimulation to release insulin. Calcium and sodium salts are taught as such salts (Col. 3, lines 20-28).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the sodium chloride in the composition of Modi with a calcium salt, such as calcium chloride (Col. 3, lines 20-28), to arrive at instant claim 4. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Modi teaches both calcium and sodium salts for use in its compositions comprising insulin, and teaches both calcium and sodium salts as opening channel in the gastrointestinal tract to stimulate the release of insulin, and
-substituting equivalents known for the same purpose is prima facie obvious, see MPEP 2144.06.
As such, an ordinary skilled artisan would reasonably expect the calcium salt, in the composition of Modi, to open channels in the gastrointestinal tract to stimulate the release of insulin, and form a salt with the chenodeoxycholate, an acid.
Regarding claim 7, Modi teaches its compositions as comprising chenodeoxycholate.
Double Patenting
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.
Claims 3, 5-6, 8-9, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US 9,918,850 (published 2018, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 3, 5, and 19, ‘850 claims a composition comprising one or more therapeutic peptides or polypeptides and chenodeoxycholate, an inhibitor of gut serine protease (claim 1).
Further regarding claim 3, since ‘850 claims a composition comprising chenodeoxycholate and a therapeutic peptide or polypeptide, the composition of ‘850 is prepared for simultaneous delivery to a subject.
Regarding claim 6, ‘850 claims peptides and polypeptides.
The following are intended use recitations:
-claim 3, last two lines, and claim 5, last 3 lines, “for the treatment of a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject,”
-claim 8, line 2, “wherein the product is delivered to the gut,”
-claim 9, lines 2-end, “wherein (i) the compound is present in the intestine in a concentration of between 0.10 to 10 mg/ml. . .(iv) the compound is present in the intestine in a concentration of between 0.2 to 1 mg/ml.”
The instant claims are product claims and not method of use claims. Since the composition of ‘850 is capable of performing the intended use, it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Further regarding the wherein clauses in claims 8-9, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, ’” MPEP 2111.04.
In the instant case, these wherein clauses express the desired result of the intended use of administering the composition of ‘850. As such, the composition taught by ‘850 meets these limitations.
Claims 3, 5-6, 8-9, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-13 of U.S. Patent No. US 9,987,232 (published 2018, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 3, 5-6, and 19, ‘232 claims a composition comprising propyl gallate and an active macromolecular principle, such as insulin and other therapeutic compounds taught in instant claim 6 (claims 1-6, 9-13).
Further regarding claim 3, since ‘232 claims a composition comprising propyl gallate and insulin, the composition of ‘232 is prepared for simultaneous delivery to a subject.
The following are intended use recitations:
-claim 3, last two lines, and claim 5, last 3 lines, “for the treatment of a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject,”
-claim 8, line 2, “wherein the product is delivered to the gut,”
-claim 9, lines 2-end, “wherein (i) the compound is present in the intestine in a concentration of between 0.10 to 10 mg/ml. . .(iv) the compound is present in the intestine in a concentration of between 0.2 to 1 mg/ml.”
The instant claims are product claims and not method of use claims. Since the composition of ‘232 is capable of performing the intended use, it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Further regarding the wherein clauses in claims 8-9, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, ’” MPEP 2111.04.
In the instant case, these wherein clauses express the desired result of the intended use of administering the composition of ‘232. As such, the composition taught by ‘232 meets these limitations.
Claims 3, 5-6, 8-9, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-11 of U.S. Patent No. US 7,651,995 (published 2010, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 3, 5, and 19, ‘995 claims a method of enhancing absorption of an active macromolecular principle which is a polypeptide or protein, polynucleotide or polysaccharide by administering an absorption enhancer such as propyl gallate (claims 1, 3).
Further regarding claim 3, since ‘995 claims a method on enhancing absorption of insulin comprising administering propyl gallate and insulin, the composition of ‘995 is prepared for simultaneous, separate, or sequential delivery to a subject.
Regarding claim 6, ‘995 claims insulin (claims 8-10).
The following are intended use recitations:
-claim 3, last two lines, and claim 5, last 3 lines, “for the treatment of a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject,”
-claim 8, line 2, “wherein the product is delivered to the gut,”
-claim 9, lines 2-end, “wherein (i) the compound is present in the intestine in a concentration of between 0.10 to 10 mg/ml. . .(iv) the compound is present in the intestine in a concentration of between 0.2 to 1 mg/ml.”
The instant claims are product claims and not method of use claims. Since the composition of ‘995 is capable of performing the intended use, it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Further regarding the wherein clauses in claims 8-9, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, ’” MPEP 2111.04.
In the instant case, these wherein clauses express the desired result of the intended use of administering the composition of ‘995. As such, the composition taught by ‘995 meets these limitations.
Claims 3, 5-6, 8-9, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 9-10, 21-23 of U.S. Patent No. US 8,314,058 (published 2012, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 3, 5-6, and 19, ‘058 claims a composition comprising an active macromolecular principle which is a polypeptide or protein, polynucleotide, or polysaccharide, such as insulin, a non-conjugated bile acid or salt, such as chenodeoxycholate, and an additive such as propyl gallate (claims 1, 6-7, 9-10, 21-23).
Further regarding claim 3, since ‘058 claims a composition comprising chenodeoxycholate, propyl gallate and an n active macromolecular principle, the composition of ‘058 is prepared for simultaneous delivery to a subject.
The following are intended use recitations:
-claim 3, last two lines, and claim 5, last 3 lines, “for the treatment of a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject,”
-claim 8, line 2, “wherein the product is delivered to the gut,”
-claim 9, lines 2-end, “wherein (i) the compound is present in the intestine in a concentration of between 0.10 to 10 mg/ml. . .(iv) the compound is present in the intestine in a concentration of between 0.2 to 1 mg/ml.”
The instant claims are product claims and not method of use claims. Since the composition of ‘058 is capable of performing the intended use, it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Further regarding the wherein clauses in claims 8-9, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, ’” MPEP 2111.04.
In the instant case, these wherein clauses express the desired result of the intended use of administering the composition of ‘058. As such, the composition taught by ‘058 meets these limitations.
Claims 3, 5-6, 8-9, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-10, 14-15, 17, 23-26, 30-31 of U.S. Patent No. US 7,303,762 (published 2007, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 3, 5-6, and 19, ‘762 claims a composition comprising an active principle which is a polypeptide or protein, such as insulin, an absorption enhancer, and an agent which assists in solubilizing the active principle, such as chenodeoxycholate (claims 1, 7-10, 14-15, 17, 23-26, 30-31).
Further regarding claim 3, since ‘762 claims a composition comprising chenodeoxycholate, and an active principle, such as insulin, the composition of ‘762 is prepared for simultaneous delivery to a subject.
The following are intended use recitations:
-claim 3, last two lines, and claim 5, last 3 lines, “for the treatment of a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject,”
-claim 8, line 2, “wherein the product is delivered to the gut,”
-claim 9, lines 2-end, “wherein (i) the compound is present in the intestine in a concentration of between 0.10 to 10 mg/ml. . .(iv) the compound is present in the intestine in a concentration of between 0.2 to 1 mg/ml.”
The instant claims are product claims and not method of use claims. Since the composition of ‘762 is capable of performing the intended use, it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Further regarding the wherein clauses in claims 8-9, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, ’” MPEP 2111.04.
In the instant case, these wherein clauses express the desired result of the intended use of administering the composition of ‘762. As such, the composition taught by ‘762 meets these limitations.
Claims 3, 5-6, 8-9, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-9 of U.S. Patent No. US 6,258,377 (published 2001, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 3, 5-6, and 19, ‘377 claims a composition comprising an amphiphile, such as chenodeoxycholate, and a protein such as insulin (claims 1, 5-9).
Further regarding claim 3, since ‘377 claims a composition comprising chenodeoxycholate, and protein, such as insulin, the composition of ‘377 is prepared for simultaneous delivery to a subject.
The following are intended use recitations:
-claim 3, last two lines, and claim 5, last 3 lines, “for the treatment of a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject,”
-claim 8, line 2, “wherein the product is delivered to the gut,”
-claim 9, lines 2-end, “wherein (i) the compound is present in the intestine in a concentration of between 0.10 to 10 mg/ml. . .(iv) the compound is present in the intestine in a concentration of between 0.2 to 1 mg/ml.”
The instant claims are product claims and not method of use claims. Since the composition of ‘377 is capable of performing the intended use, it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Further regarding the wherein clauses in claims 8-9, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, ’” MPEP 2111.04.
In the instant case, these wherein clauses express the desired result of the intended use of administering the composition of ‘377. As such, the composition taught by ‘377 meets these limitations.
Claims 3, 5-6, 8-9, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 11, 13, 15-16, 19, 21-22, 29-32, 35 of copending Application No. 17/794,747 (claim set dated 07/22/2022, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 3, 5, and 19, ‘747 claims a composition comprising a therapeutic compound and chenodeoxycholic acid (claims 1, 29).
Further regarding claim 3, since ‘747 claims a composition comprising chenodeoxycholate and a therapeutic peptide, the composition of ‘747 is prepared for simultaneous delivery to a subject.
Regarding claim 6, ‘747 claims a protein as the therapeutic compound (claims 3, 35).
The following are intended use recitations:
-claim 3, last two lines, and claim 5, last 3 lines, “for the treatment of a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject, or for preventing a disease or condition affecting the subject,”
-claim 8, line 2, “wherein the product is delivered to the gut,”
-claim 9, lines 2-end, “wherein (i) the compound is present in the intestine in a concentration of between 0.10 to 10 mg/ml. . .(iv) the compound is present in the intestine in a concentration of between 0.2 to 1 mg/ml.”
The instant claims are product claims and not method of use claims. Since the composition of ‘747 is capable of performing the intended use, it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Further regarding the wherein clauses in claims 8-9, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, ’” MPEP 2111.04.
In the instant case, these wherein clauses express the desired result of the intended use of administering the composition of ‘747. As such, the composition taught by ‘747 meets these limitations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Examiner, Art Unit 1622
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