DETAILED ACTION
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 .
Applicant’s Appeal Brief filed March 10, 2026 and the correction on August 10, 2026 in response to the Final Office Action on August 11, 2025 has been received and entered into the case.
Claims 1 - 2, 4 - 5, 7, 9 - 12, 14 - 20 and 23 - 26 are pending and have been considered on the merits insofar as it reads on the elected species of SEQ ID NO: 28. All arguments have been fully considered.
Priority
The instant application is a Continuation in Part to US Application 16/357 884. The subject matter of claims 4, (e.g., a color assay) and 7 do not find support in the earlier filed application and are therefore afforded the priority date of July 19, 2021, or the filing date of the instant application. The subject matter of claims 1 – 2, 5, 8 – 12 and 14 – 20 finds support in the prior filed application and is granted the priority date of April 9, 2015.
Claim Objections
Claim 25 remains objected to under 37 CFR 1.75 as being a substantial duplicate of claim 9. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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 1 – 2, 4 – 5, 7, 9 – 12, 14 – 20 and 23 – 26 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.
Claim 1 and its dependents are drawn to a composition comprising an enzyme, dispersing agent and signal peptide, however, are rendered indefinite for reciting "comprising of SEQ ID NOS. 1-34" because it is unclear if the signal peptide comprises all of the sequences, any one of the sequences, any combination of sequences, or any partial sequences therein. The phrase is further indefinite because it recites a period rather than a colon.
Claim 4 and its dependent are drawn to a composition. However, the claim and its dependent are rendered indefinite for reciting the formulation “is tested via…assays” since it is unclear what is being tested or tested for. Moreover, it is unclear how the claims intend to limit the composition. For purposes of examination, the claims are interpreted to mean that the compositions are tested in some manner for some undefined parameter, or as intended uses of the composition itself. In this regard, the claims are not considered to further limit the composition itself but merely recite a manner in which the compositions can be used or tested.
Claims 9 and 25 are identical claims and are rendered indefinite as it is unclear if the claims recited proper dependency.
Claim 24 is drawn to a composition however is rendered indefinite as the claim attempts to further define an aqueous formulation as lyophilized, which is no longer aqueous. Moreover, the claim appears to change the scope of the claim on which it depends rather than further define the claim on which it depends. For purposes of examination, the limitation is interpreted as an intended use of the aqueous formulation, e.g., the aqueous formulation can be lyophilized and does not further limit the aqueous formulation.
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 24 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 24 is drawn to a composition however the claim attempts to further define an aqueous formulation as lyophilized, which effectively renders the formulation no longer aqueous. Moreover, the claim changes the scope of the claim on which it depends rather than further defines the claim on which it depends. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
Previous rejections under 35 U.S.C. 102al as being anticipated by Matalon (US 2003/0215432, IDS 07.20.021 USPAP #1) are withdrawn. Matalon teaches compositions for subcutaneous administration (0026, 0059, 0068) comprising alpha galactosidase (LSDRE) and hyaluronidase (dispersing agent) (abstract, 0010) together (claims 44,47,77,80,109, 0037, 0047, 0059, 0061, 0062, 0068, 0073, 0074) (a stable formulation) in a solution (0026, 0036 – 0037, 0043). However, the reference does not expressly state the solution is aqueous.
Claim Rejections - 35 USC § 103
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.
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 1 – 2, 4 – 5, 7, 9 – 12, 14 – 20, 23 – 26 are rejected under 35 U.S.C. 103 as being unpatentable over Matalon (US 2003/0215432, IDS 07.20.021 USPAP #1) in view of Bookbinder et al. (US 7767429) and Moloney et al. (US 7547821).
Regarding claims 1 – 2, 11, 20 and 23, Matalon teaches compositions for subcutaneous administration (0026, 0059, 0068) comprising alpha galactosidase (LSDRE) and hyaluronidase (dispersing agent) (abstract, 0010) together (claims 44,47,77,80,109, 0037, 0047, 0059, 0061, 0062, 0068, 0073, 0074) in a solution (0026, 0036 – 0037, 0043) (a stable formulation).
Matalon does not teach the composition wherein it is an aqueous formulation. However, Matalon teaches the compositions are included in "a suitable carrier" conventional in the art such as solutions for subcutaneous delivery (0026, 0036, 0043, 0053, 0059, 0068). At the time the claims were filed aqueous solutions were well known and conventional carrier formulations for subcutaneous compositions comprising hyaluronidase. In support, Bookbinder teaches stable compositions comprising hyaluronidase for subcutaneous delivery formulated with aqueous carriers (col.7 line 55-60, col.23 line 53 - 60, col.63 - 64, col.75 and claims 15, 27, 44, 46) to include water, saline and various buffers (col.63 - 64). Bookbinder teaches the compositions act to facilitate subcutaneous delivery and distribution of drugs, particularly those that alleviate glycosaminoglycan associated pathologies (e.g., lysosomal storage disorders) (abstract, col.8 line 25 - 38, 60 - 65; col.56 line 36 - 43; col.76 line 33 - 60). As such, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to formulate the subcutaneous compositions of Matalon in an aqueous solution since it was a well known and conventional carrier therefor, as evidenced by Bookbinder.
Matalon does not teach the hyaluronidase having a non-native signal peptide as claimed therein. However, Matalon teaches the hyaluronidase may be produced recombinantly using conventional techniques in the art (0025). At the time the claims were filed, non-native signal peptides were commonly used when producing recombinant hyaluronidase for the purpose of increasing secretion. In support, Bookbinder teaches compositions comprising recombinant hyaluronidase for subcutaneous delivery of therapeutics wherein the hyaluronidase includes a non-native leader peptide (signal peptide) in the amino acid sequence thereof (abstract, col.3 line 50 - col.4 line 10, example 5). Bookbinder teaches that the leader peptide (signal peptide) enhances secretion of hyaluronidase (abstract, example 5) resulting in a more effective therapeutic. In this regard, at the time the claimed were filed one of ordinary skill in the art would have been motivated by Bookbinder to use a hyaluronidase including a non-native signal peptide in the composition of Matalon for the disclosed advantages of higher secretion and therapeutic value.
The combined references do not teach the claimed signal peptide sequences. However, at the time the claims were filed, the claimed sequences were known signal peptides in the art. In support, Moloney teaches claimed SEQ ID NO: 28 is a known signal peptide (sequence 28). In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to use the instant signal peptide in the recombinant production of hyaluronidase since it was a conventional and known technique as evidenced by the combined teachings of Bookbinder and Moloney.
Regarding claims 4 – 5 and 7, it is initially noted that the claims are drawn to an intended use of the composition and do not further limit the claimed composition. Moreover, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Notwithstanding, Matalon teaches the hyaluronidase (dispersing agent) can be assayed by convention techniques described by Hynes et al. (1994) which is incorporated by reference and teaches fluorogenic assays (p.610), colorimetric assays such as Reissig’s method, or a modified Morgan-Elson reaction, (p.612-613, see also Reissig et al., 1955), and turbidometric assays (direct measure of enzymatic products, per applicant’s specification paragraph 0050).
Regarding claims 9, 18 and 25 although the combined references do not teach the formulations are stable when stored as claimed, the composition obtained by the combined teachings thereof results in a composition comprising the claimed components. In this regard, the composition would also be stable when stored. As such, absent evidence to the contrary, it is surmised that the stable formulations of Matalon and Bookbinder must also exhibit the claimed stability under the claimed conditions. Please note that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new. As such, the claiming of a new use, functions or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (MPEP 2112).
Regarding claim 10, Matalon teaches the enzyme (LSDRE) used can be of natural origin (i.e., extracted from natural sources) (0070). Since the subject are mammalian (0066), one in the art would understand a natural source to be that of the subject, or mammalian.
Regarding claim 12, Matalon does not teach compositions with the claimed amounts of GLA. However, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the amounts of GLA since it was an identified active component of the composition (0055), or a recognized result effective variable that would be routinely optimized as a matter of standard practice and experimentation. In support, Matalon teaches the amounts and forms of the enzymes administered will vary based on the patient, which can be considered by one of ordinary skill in the art (0045).
Regarding claim 14, Matalon teaches the hyaluronidase is mammalian (or animal derived) (0025).
Regarding claims 15 – 16, the claims recite a way to package the instant composition. In this regard, the limitations are considered an intended placement or use of (e.g., place the composition into a syringe) the composition itself and do not further limit the composition itself. As it pertains to “a lyophilized form” and “diluent” recited in claim 16, it is noted that the claims fail to specifically further limit the composition of claim 1. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claim 17, Matalon does not teach the compositions with the claimed ratio of LSDRE to hyaluronidase. However, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the amounts of the enzymes since they were both identified as active component of the composition (0045), or a recognized result effective variable that would be routinely optimized as a matter of standard practice and experimentation. In support, Matalon teaches the amounts and forms of the enzymes administered may vary based on the patient, enzyme used, mode of administration and condition of the subject, which can be taken into account by one of ordinary skill in the art (0045). Thus, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the amounts of LSDRE and hyaluronidase and ratios thereof as a matter of routine experimentation and with a reasonable expectation for successfully obtaining an effective subcutaneous formulation.
Regarding claims 19 – 20, Matalon teaches the LSDR is alpha galactosidase (LSDRE) (abstract, 0010).
Regarding claim 24, the claim appears to recite an intended or later use of the aqueous formulation required by claim 1. In this regard, lyophilizing the aqueous solution later does not materially change the aqueous solution, but rather recites an intended use. Moreover, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claim 26, Matalon does not teach the composition comprising the claimed amount of LSDRE. However, Matalon teaches that the amount of enzyme to be administered will vary according to the particular compound, the particular composition formulated, and the mode of administration wherein many factors such as body weight, sex, diet, time of administration, route of administration, rate of excretion, condition of the subject, drug combinations, and reaction sensitivities and severities can be taken into account by those skilled in the art. Specifically, Matalon teaches that administration of doses are optimized and can be ascertained by those skilled in the art using conventional dosage administration tests (0045). Thus, at the time the claims were filed, one of ordinary skill in the art would have been motivated to optimize the amount of enzyme administered as specifically directed by Matalon.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
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 1 – 2, 4 - 5, 7, 9 – 12, 14 – 20 and 23 – 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims:
1 – 6, 9, 12, 14 – 15 of U.S. Patent No. 11065309;
1 – 8 and 10 – 13 of U.S. Patent No. 10286045; and
1 – 5, 8 and 9 – 14 of U.S. Patent No. 9981021, in view of Bookbinder et al. (US 7767429) and Moloney et al. (US 7547821).
Regarding claims 1 – 2, 9, 11 – 12, 14, 18 – 20, 23 and 25 all claim sets encompass a composition comprising alpha galactosidase (LSDRE) and hyaluronidase (dispersing agent) together in a stable formulation having the same stability parameters, amount of GLA and source of enzymes. The issued claims do not include a hyaluronidase with the instantly claimed non-native signal peptide attached thereto. However, they each claim a recombinant hyaluronidase. At the time the claims were filed, non-native signal peptides were commonly used when producing recombinant hyaluronidase. In support, Bookbinder teaches compositions comprising recombinant hyaluronidase for subcutaneous delivery of therapeutics wherein the hyaluronidase includes a non-native leader peptide (signal peptide) in the amino acid sequence thereof (abstract, col.3 line 50 - col.4 line 10, example 5). Bookbinder teaches that the leader peptide (signal peptide) enhances secretion of hyaluronidase (abstract, example 5) resulting in a more effective therapeutic. In this regard, at the time the claimed were filed one of ordinary skill in the art would have been motivated by Bookbinder to use a hyaluronidase including a non-native signal peptide in the composition of Matalon for the disclosed advantages of higher secretion and therapeutic value. Moloney teaches the claimed SEQ ID NO: 28 as a known signal peptide (sequence 28). In this regard, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to use the instant signal peptide in the recombinant production of hyaluronidase since it was a conventional and known technique as evidenced by the combined teachings of Bookbinder and Moloney.
Regarding claims 4 – 5 and 7, the intended use of the instantly claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claim 10, the issued patents all indicate the LSDRE is mammalian (per examples and throughout).
Regarding claims 15 – 16, the instant claims recite a manner in which to package the instant composition. In this regard, the limitations are considered an intended placement or use of (e.g., place the composition into a syringe) the composition itself and do not further limit the composition itself. As it pertains to “a lyophilized form” and “diluent” recited in claim 16, it is noted that the claims fail to specifically further limit the composition of claim 1.
Regarding claim 24, lyophilizing the aqueous solution later does not materially change the aqueous solution, but rather recites an intended use. Moreover, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting.
Regarding claims 17 and 26, it would have been obvious to one of ordinary skill in the art to optimize the amounts of the enzymes since they were both identified as active components of the compositions, or are recognized result effective variables that would be routinely optimized as a matter of standard practice and experimentation and with a reasonable expectation for successfully obtaining an effective subcutaneous formulation.
Response to Arguments
Applicant argues that Matalon does not teach the LSDRE is in an amount suitable for facilitating subcutaneous or intradermal delivery; and that no proof or explanation has been provided to show the composition of the prior art is stable for at least 3 months when stored at 2 - 8C.
However, these arguments fail to persuade because Matalon expressly teaches solutions for subcutaneous administration (0026, 0036, 0040, 0059, 0073, claims 44 and 47), indicating the components therein are in amounts suitable for subcutaneous delivery.
Regarding evidence of the claimed stability, the claims does not recite or require any additional elements other than an LSDRE enzyme, dispersing agent, and signal peptide wherein the dispersing agent is included in an amount to administer the enzyme subcutaneously. Moreover, no additional structural limitations are recited to achieve the functional outcome of remaining stable for at least 3 months when stored at 2 - 8C. In this regard, the functional outcome must result from the only claimed elements - that is the enzyme, dispersing agent and signal peptide, wherein the dispersing agent is in an amount for subcutaneous delivery. Since the combined prior art teaches the claimed structural elements, it must also exhibit the claimed functional outcome, absent evidence of an unexpected result or advantage.
Applicant states that Matalon is drawn to increasing blood brain barrier permeability; teaches suspensions and not aqueous solutions; and does not teach the claimed signal peptides attached to the hyaluronidase.
However, these arguments fail to persuade. Regarding the statement that Matalon is drawn to methods of increasing blood brain barrier permeability, it is unclear how applicant intends the statement to rebut the rejected claims. As it applies to the intended use of a composition in the prior art, it is not necessary that the prior art use the composition for the same purpose as applicant. Moreover, the claims are not drawn to a method but a composition. As such the argument is not commensurate in scope with the claimed invention. Notwithstanding, Matalon teaches the compositions are administered to any tissue (0065 - 0066) and are for subcutaneous delivery (0026, 0036, 0043, 0053, 0059, 0068) as claimed. Note that the claimed composition does exclude compositions that result in increasing blood brain barrier permeability.
Regarding the argument that Matalon does not teach an aqueous solution, as stated in the rejection above, Matalon teaches the compositions are included in "a suitable carrier" conventional in the art such as solutions (aqueous formulations are solutions by definition) for subcutaneous delivery (0026, 0036, 0043, 0053, 0059, 0068) and aqueous formulations were well known, conventional carriers for subcutaneous compositions of hyaluronidase as evidenced by Bookbinder.
Regarding the argument that Matalon does not teach the claimed signal peptides, as stated in the rejection above, Matalon teaches the compositions may include recombinant hyaluronidase produced using conventional techniques known to those skilled in the art (0025) while Bookbinder teaches recombinant hyaluronidase with non-native signal peptides in the amino acid sequences therein for the purpose of increased hyaluronidase secretion and therapeutic value. Further, Moloney teaches claimed SEQ ID NO: 28 is a known signal peptide (sequence 28). In this regard, it is maintained that at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to use the instant signal peptide in the recombinant production of hyaluronidase since it was a conventional and known technique as evidenced by the combined teachings of Bookbinder and Moloney.
Applicant argues the references individually in that Matalon does not teach or suggest a hyaluronidase with the claimed signal peptide; that Moloney does not cure the deficiency but is irrelevant in that Moloney produces insulin in plants and that while the references teaches SEQ ID NO: 28, it does not teach it for use in intradermal or subcutaneous delivery.
However, these arguments fail to persuade.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection above is not based on any single reference alone, but the combination of prior art references. The combination of Matalon and Bookbinder specifically teaches an aqueous composition for subcutaneous injection comprising an LSDRE enzyme, dispersing agent, and signal peptide while Moloney teaches the claimed signal peptide sequence was known in the art. Thus, it is maintained that it would have been obvious to use known signal peptides in the composition obtained by the combined teachings of Matalon and Bookbinder as a matter of conventional practice and routine experimentation, and with a reasonable expectation for successfully obtaining an effective therapeutic composition.
Applicant argues that the combined references do not predict a composition comprising an LSDRE and dispersing agent together in a stable formulation as claimed.
However, this argument fails to persuade because Matalon expressly teaches solutions for subcutaneous administration comprising an LSDRE and hyaluronidase, indicating the hyaluronidase is in an amount suitable for subcutaneous delivery; Bookbinder specifically teaches stable aqueous compositions for subcutaneous injection comprising hyaluronidase and a signal peptide; and Moloney teaches the claimed signal peptide sequence was known in the art. Thus, it is maintained that it would have been obvious to use known signal peptides in the composition obtained by the combined teachings of Matalon an Bookbinder as a matter of conventional practice and routine experimentation, and with a reasonable expectation for successfully obtaining an effective therapeutic composition, especially absent evidence to the contrary. It is iterated that since the combined prior art teaches also teaches the claimed structural elements, it must also exhibit the claimed functional outcome.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached on Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
