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 .
Priority
The instant application is a national stage entry of PCT/US2020/062475 (filed 11/27/2020). Acknowledgement is made of Applicants’ claim for benefit of prior-filed US Provisional application 62/941382 (filed 11/27/2019).
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a product comprising acellular extract of placental tissue and a solvent, in the reply filed on 8/12/2026 is acknowledged. Claims 1, 3, 4 and 6-12 read on the elected invention. Claims 18-24 and 27-29 are withdrawn from consideration at this time.
Claim Interpretation
Claim 1 is drawn to an oral formulation. The recitation “oral formulation” in the preamble serves to limit the composition to one which can physically be taken by the oral route.
An ‘extract’ is being interpreted as any portion or fraction that is less than the whole original tissue and devoid of original cellular structure. Extracts may include cells, cell fragments, DNA, RNA, protein, etc. The instant claim specifies the extract is acellular. There is no explicit definition for ‘acellular extract’ in the specification, so the broadest reasonable interpretation will cover any individual, acellular element from the tissue, e.g. isolated proteins, isolated nucleic acids, etc, as well as acellular fractions comprising multiple acellular elements from the tissue, e.g. a combination of specific proteins, all proteins from the cell, the entire acellular portion of the extract.
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 3 and 6 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.
Regarding claim 3: Claim 3 states the placental tissue, from which the acellular extract is derived, further comprises a villous chorion. Because the villous chorion is part of the placental disc, it is unclear what the claim is requiring. It is unclear if the claim is simply specifying an inherently present portion of the placental disc (in which case the claim does not further limit the parent claim), or if the claim is requiring additional villous chorion from a separate placenta.
Regarding claim 6: There is insufficient antecedent basis for the limitation the milk in claim 6, as parent claim 4 recites two types of milk. It is thus not clear which milk is being further limited.
Furthermore, it is unclear how dehydrated milk serves as a solvent. A solvent must dissolve another substance. Dehydrated milk cannot dissolve another substance.
Claim Rejections - 35 USC § 112
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 3 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.
This rejection is made over the interpretation that claim 3 is simply specifying an inherently present portion of the placental disc.
Claim 3 requires the placental tissue from which the acellular extract is derived to further comprise villous chorion. However, parent claim 1 requires the placental tissue from which the acellular extract is derived to comprise a placental disc. Villous chorion is part of the placental disc. In support, see Varney’s Midwifery. Varney’s Midwifery at Pg 565-566 states the villous chorion is the fetal contribution to the placental disc. The chorionic villi are part of the villous chorion (See Fig. 21-7). The chorionic villus tree is the same as the villus chorion. The chorionic villi are part of the chorionic villus tree/villus chorion.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-4 and 6-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature judicial exception without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation.
Regarding claims 1, 3, 4, 6, and 7: The claims are directed to a composition, which is a statutory category of invention (Step 1: YES).
The claim recite an acellular extract of placental tissue comprising a placental disc …comprising a villous chorion. The placenta is a naturally occurring organ. The placental disc and its villous chorion are part of the placental organ (See Varney’s Midwifery). Proteins that naturally exist in the placental disc and that can be extracted therefrom include, inter alia, GCP-2, IL-8, IL-2, MCP-1, MIF (See WO 17/160804, Pg 20, Table 1). Isolation of the proteins does not alter their structure or chemistry, and thus they are considered product of nature judicial exceptions. Any of these proteins, isolated, or in combination, read on acellular extract of placental tissue comprising a placental disc.
The claim also recites a solvent. Under broadest reasonable interpretation, the solvent can be water. Claim 4 lists water an option. In claim 7, water will also satisfy the diluent, excipient or carrier. Alternatively, the solvent can be naturally mammalian milk. Both water and naturally mammalian milk are products of nature judicial exceptions.
Each of the isolated proteins and water (or milk), are, individually, nature-based products. When a claimed composition includes nature-based products, further analysis is taken to determine if the claimed composition recites a nature-based product judicial exception by comparing the claimed composition to the closest naturally occurring counterpart to determine if the claimed composition has markedly different characteristics than the counterpart. In the instant case, the composition, as a whole (i.e. in combination), does not clearly exist in nature, thus there is no naturally occurring counterpart. However, simply because a combination of nature-based products does not exist in nature does not mean the claim is not directed to a product of nature judicial exception. When a claim is to a combination of multiple nature-based products and the composition as a whole (i.e. in combination) does not exist in nature, comparison is made between each of the individual nature-based products in the composition and their respective naturally occurring counterparts. In the instant case, the claimed composition can consist of isolated proteins listed above, and water (or milk). Each of the isolated proteins and water are naturally occurring substances that exist in nature. There is no indication or evidence in the specification or prior art that combining these individual natural products together results in any structural, chemical or functional change to any one or more of the individual products; thus, even in combination none of the individually recited components are markedly different from their respective naturally occurring counterparts. The recited concentrations of isolated proteins and water (or milk) do not have any effect on their properties in the composition. When multiple nature-based products are provided in combination, but the combination does not impart any change to the individual components (i.e. the individual components are not incorporated into a higher ordered structure, or physically or chemically changed due to the combination), then the nature-based products must be considered independently from one another. Therefore, while the composition as a whole does not exist in nature, the composition includes at least two nature-based product which are not markedly different from their individual respective naturally occurring counterparts (isolated proteins, such as GCP-2, and water (or milk)). Each of the nature-based products are thus considered to be products of nature, and thus the claim is considered directed to at least one product of nature judicial exception (Step 2A, prong 1: YES).
The claim does not integrate the product into a practical application because the claim is to the composition, per se, not a method of use. (Step 2A, Prong 2: NO).
Next, the claim as a whole is analyzed to determine whether any additional element, or combination of elements, is provided for that will elevate the claim to amount to significantly more than the at least one judicial exception. Because the combination of products of nature do not occur together in nature and are not markedly changed by their combination into a mixture, each is considered as an additional element to the other. This consideration provides an opportunity to explore whether this combination of “products of nature” amounts to significantly more than the products themselves. As discussed above, there is no evidence that providing the combination of products together markedly changes the characteristics of any one product, because each product continues to have the same properties in the mixture as it had alone. There are no additional components beyond the two products of nature discussed above. Therefore the claims do not include any additional features that add significantly more to the judicial exceptions (Step 2B: NO).
The claims are patent ineligible.
Regarding claim 10: Natural mammalian milk contains various vitamins and minerals. Thus claim 10 does not add additional elements. The analysis above for the embodiments wherein natural mammalian milk is the solvent are applicable to claim 10.
Regarding claim 12: Claim 12 defines the concentration of proteins present in the composition. The concentration of a protein does not change the overall composition, nor differentiate it from the isolated proteins discussed and analyzed above. The analysis for claim 1 is applicable to claim 12.
Regarding claims 8, 9 and 11: Each of these claims require an additional element: either a protease inhibitor or an antibiotic. Naturally occurring versions of each exist: bovine lung aprotinin is a naturally occurring protease inhibitor. Penicillin is a naturally occurring antibiotic.
Each of these additional elements themselves are product of nature judicial exceptions. As discussed above, there is no evidence that providing these elements in combination with the isolated placental proteins and water (or milk) will markedly change the characteristics of any one product, because each product continues to have the same properties in the mixture as it had alone. Therefore the provision of these additional products of nature do not change the analysis of each individual product of nature, nor add significantly more to the judicial exceptions.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3, 4, 7-10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Washburn et al (WO 17/160804).
Washburn et al discloses placental tissue products and compositions (abstract & ¶24). In Example 2 (¶84-96) Washburn et al teaches producing a placental homogenate (PH) by procuring and homogenizing the complete placental disc. The homogenized placental disc was extracted using protease inhibitors AEBSF, aprotinin, E-64, and leupeptin (referencing “PI” from ¶78) in PBS to form an acellular extract.
Washburn et al disclose pharmaceutical compositions comprising the placental tissue products disclosed therein (¶44). The pharmaceutical compositions can comprise, inter alia, diluents, excipients, carriers and other substances necessary to increase bioavailability or extend the lifetime of the ingredients/compounds of their invention (See ¶44). Washburn et al disclose solvents can include inter alia, water (See ¶55).
Washburn et al teach the pharmaceutical composition can be in the form of an oral formulation, and can contain sweeteners and additives to make it palatable (See ¶49). Ascorbic acid can be included in oral formulations to serve as a preservative (See ¶49).
Regarding claims 1 and 2: Referring to the placental homogenate produced in Example 2: the filtrate retained at the conclusion of Step 5 is considered an acellular extract of placental tissue. The placental homogenate is in a liquid form. It has been produced using PBS. The PBS liquid reads on a solvent. A liquid form can be orally consumed, so it satisfies the limitation that it is an oral formulation. Example 2 processes complete placenta, which will comprise the placental disc, including the villous chorion.
Regarding claims 4 and 7: Following the discussion of claim 1 above, PBS contains water.
Furthermore, Washburn et al teach that the placental homogenate can be lyophilized (Step 6). Washburn et al further teach that the placental products can be combined with various diluents, including water. This means the lyophilized PH can be combined with water.
Regarding claims 8 and 9: Following the discussion of claim 1 above, the placental homogenate is extracted with protease inhibitors AEBSF, aprotinin, E-64 and leupeptin. At least residual amounts of each of these protease inhibitors will remain in the extracted product.
Furthermore, Washburn et al teach protease inhibitors can be specifically added to the placental product (See ¶30-32).
Regarding claim 10: Following the discussion of claim 1, Washburn et al teach that the placental homogenate can be lyophilized (Step 6). Washburn et al further teach that the placental products can be combined with, inter alia, ascorbic acid (vitamin C).
Regarding claim 12: At Table 1, Washburn et al report on the concentration of various proteins in the placental extract. The composition extracted in the presence of protease inhibitors comprises GCP2 at 432.4 pg/mL (4.324 x 10-7 mg/mL, which is under 25 mg/mL).
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.
Claims 4, 6, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Washburn et al (WO 17/160804).
The teachings of Washburn et al are set forth above.
Regarding claim 11: Washburn et al does not teach inclusion of an antibiotic. However, Washburn et al does teach that the pharmaceutical composition can be combined with “antimicrobial preservatives” (See ¶47). It is submitted that one having ordinary skill in the art would have found inclusion of antibiotics as an obvious version of an antimicrobial preservative.
Regarding claims 4 and 10: Washburn teaches the pharmaceutical composition can be formulated into an oral preparation (See ¶49). Washburn et al does not teach use of mammalian milk as a carrier or additive for the oral preparation. Official notice is taken that mammalian milk, such as cow’s milk, was a well-known liquid that was considered ‘palatable’ for human oral consumption. Given that Washburn et al teach the placental product can be provided in suitable carriers (See ¶44), and given that milk was a known carrier, with the additional benefit of being recognized as generally palatable to humans, it would have been prima facie obvious to have substituted cow’s milk as the carrier for the oral preparation version of the composition of Washburn et al. Cow’s milk contains water, as well as a variety of vitamins and minerals.
Regarding claim 6: This rejection is made in so far as claim 6 can be interpreted as meaning the dehydrated milk is later reconstituted, and the reconstituted milk is the solvent. Following the discussion of claim 4 above, use of milk is prima facie obvious.
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, 3, 4 and 6-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12157899.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate and/or render obvious the instant claims as follows:
Regarding claim 1: Patented claim 17 recites a method which generates the product of instant claim 1. Specifically, at the step of ‘separating the acellular fluid from the solid cellular debris’, and prior to ‘lyophilizing or freezing the acellular fluid’, the acellular fluid anticipates the composition of claims 1, 3 and 7-9.
Furthermore, the composition of patented claims 1-16 renders obvious the composition of current claims 1, 3, and 7-9. The patented composition claims recite an acellular extract of placental tissue comprising a placental disc, and at least two exogenous protease inhibitors. The patented claims do not specify the presence of a solvent. However, given that the patented composition is intended for administration to a subject (see, e.g. patented claim 19), it would have been prima facie obvious to have provided the patented composition in a pharmaceutically acceptable carrier or diluent, such as, water.
Regarding claims 4, 6, and 10: Following the discussion of claim 1 above, selection of cow’s milk as the solvent for delivery of the acellular placental preparation of patented claims 1-16 would have been prima facie obvious. Cow’s milk was well-known as a vehicle for human consumption, and generally recognized as palatable. Cow’s milk contains various vitamins and minerals.
Regarding claim 11: Following the discussion of claim 1 above, while the patented claims do not recite inclusion of an antibiotic, at the time the application was filed, inclusion of antibiotics in pharmaceutical compositions were well known and routine. Therefore, inclusion of an antibiotic would have been prima facie obvious.
Regarding claim 12: Following the discussion of claim 1 above, dilution to the desired protein concentration would have been a matter of routine optimization based on the condition to be treated.
Claims 1, 3, 4 and 6-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/926116 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Regarding claims 1, 3 and 7-9: Reference application claim 1 recites a placenta-derived composition comprising placental tissue and one or more protease inhibitors. Reference application claim 3 specifies the placental tissue (from which the placental-derived composition is derived) is villous chorion.
Reference application claim 6 discloses a variation of the placenta-derived composition, describing its method of production, and recites lysis of cells. Reference application claim 7 further recites separation of lysed cells. Taken together, the reference application claims are considered to render obvious an acellular placenta-derived composition (reads on acellular extract).
Reference application claim 13 recites the composition further comprises, inter alia, a diluent. The diluent is considered to read on a solvent. Alternatively, provision of a solvent to provide the placenta-derived composition in a form suitable for administration would have been prima facie obvious to facilitate use in the method of reference claim 20.
Regarding claims 4, 6, and 10: Following the discussion of claim 1 above, selection of cow’s milk as the diluent (solvent) would have been prima facie obvious. Cow’s milk was well-known as a vehicle for human consumption, and generally recognized as palatable. Cow’s milk contains various vitamins and minerals.
Regarding claim 11: Following the discussion of claim 1 above, while the reference application claims do not recite inclusion of an antibiotic, at the time the application was filed, inclusion of antibiotics in pharmaceutical compositions were well known and routine. Therefore, inclusion of an antibiotic would have been prima facie obvious.
Regarding claim 12: Following the discussion of claim 1 above, dilution to the desired protein concentration would have been a matter of routine optimization based on the condition to be treated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 4 and 6-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/690211 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Regarding claims 1, 3 and 7: Reference application claims 1 and 8 teach methods of administration a placenta-derived composition. A claim to a method of administration of a composition is considered to disclose the composition, per se. Reference application claims 2 and 10 specify the placental tissue (from which the placental-derived composition is derived) is placental disc. Reference application claims 3 and 11 specify the placental tissue (from which the placental-derived composition is derived) is acellular. Taken together, these claims render obvious administration of a placenta-composition from acellular placental disc. The placental-derived composition reads on an extract. Given the source tissue is acellular, the extract, too, must be acellular. This renders obvious an acellular extract from placental disc. The placental disc contains the villous chorion. Reference application claims 5 and 13 state the placenta-derived composition further comprises, inter alia, a diluent. The diluent is considered to read on a solvent.
Regarding claims 8-9: Following the discussion of claim 1 above, reference application claims 4 and 12 teach the administered composition further comprises various protease inhibitors, including those currently claimed.
Regarding claims 4, 6, and 10: Following the discussion of claim 1 above, selection of cow’s milk as the diluent (solvent) would have been prima facie obvious. Cow’s milk was well-known as a vehicle for human consumption, and generally recognized as palatable. Cow’s milk contains various vitamins and minerals.
Regarding claim 11: Following the discussion of claim 1 above, while the reference application claims do not recite inclusion of an antibiotic, at the time the application was filed, inclusion of antibiotics in pharmaceutical compositions were well known and routine. Therefore, inclusion of an antibiotic would have been prima facie obvious.
Regarding claim 12: Following the discussion of claim 1 above, dilution to the desired protein concentration would have been a matter of routine optimization based on the condition to be treated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 4, and 6-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/260229 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims.
Regarding claims 1, 3 and 7: Reference application claims 1, 8 and 16 teach methods of administration a placenta-derived composition. A claim to a method of administration of a composition is considered to disclose the composition, per se. Reference application claims 2, 10 and 19 specify the placental tissue (from which the placental-derived composition is derived) is placental disc. Reference application claims 3, 11 and 19 specify the placental tissue (from which the placental-derived composition is derived) is acellular. Taken together, these claims render obvious administration of a placenta-composition from acellular placental disc. The placental-derived composition reads on an extract. Given the source tissue is acellular, the extract, too, must be acellular. This renders obvious an acellular extract from placental disc. The placental disc contains the villous chorion. Reference application claims 5, 13 and 21 state the placenta-derived composition further comprises, inter alia, a diluent. The diluent is considered to read on a solvent.
Regarding claims 8-9: Following the discussion of claim 1 above, reference application claims 1, 4, 12 and 20 teach the administered composition further comprises various protease inhibitors, including those currently claimed.
Regarding claims 4, 6, and 10: Following the discussion of claim 1 above, selection of cow’s milk as the diluent (solvent) would have been prima facie obvious. Cow’s milk was well-known as a vehicle for human consumption, and generally recognized as palatable. Cow’s milk contains various vitamins and minerals.
Regarding claim 11: Following the discussion of claim 1 above, while the reference application claims do not recite inclusion of an antibiotic, at the time the application was filed, inclusion of antibiotics in pharmaceutical compositions were well known and routine. Therefore, inclusion of an antibiotic would have been prima facie obvious.
Regarding claim 12: Following the discussion of claim 1 above, dilution to the desired protein concentration would have been a matter of routine optimization based on the condition to be treated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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/ALLISON M FOX/ Primary Examiner, Art Unit 1633
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